(86 days)
Not Found
No
The 510(k) summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are based on mechanical testing standards.
Yes.
The device is an intervertebral body fusion device and cervical plate/screws intended to facilitate and stabilize fusion of the cervical spine, which directly treats conditions like degenerative disc disease, trauma, and tumors.
No
The device description clearly states its purpose as an intervertebral body fusion device and cervical plate/screws used for maintaining disc space distraction and stabilizing the spine to facilitate fusion. This describes a therapeutic, rather than a diagnostic, function.
No
The device description clearly states that the ACCUFUSE Cervical System consists of "intervertebral body fusion devices along with cervical plates and screws," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant (intervertebral body fusion device, cervical plate/screws) used to facilitate fusion and provide temporary stabilization in the cervical spine. This is a therapeutic and structural function within the body.
- Device Description: The description details the physical components of the implant (cages, plates, screws) and their mechanical function in maintaining disc space and providing fixation.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The ACCUFUSE Cervical System is a medical device, specifically a surgical implant, used for spinal fusion.
N/A
Intended Use / Indications for Use
The ACCUFUSE Cervical System (intervertebral body fusion device) is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACCUFUSE Cervical System implants are placed via an anterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ACCUFUSE Cervical System implants are to be used with supplemental fixation. Patients should have at least six weeks of nonoperative treatment prior to surgery.
The ACCUFUSE Cervical System (cervical plate/screws) is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spimal fusion in patients with:
•degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
•spondylolisthesis,
•trauma (i.e. fractures or dislocations),
•tumors,
•deformity (defined as kyphosis, lordosis, or scoliosis),
•pseudarthrosis,
•failed previous fusion,
•spinal stenosis
Product codes (comma separated list FDA assigned to the subject device)
ODP, KWO
Device Description
The ACCUFUSE Cervical System consists of intervertebral body fusion devices along with cervical plates and screws used to maintain disc space distraction in skeletally mature adults requiring an intervertebral body fusion. It is designed to be used in conjunction with supplemental spinal fixation instrumentation. The implant is available in a range of footprints and heights to suit each individual's pathology and anatomical conditions of the patient. The implant has a hollow center to allow placement of autogenous bone graft to promote intervertebral body fusion. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent implant migration and/or expulsion.
The ACCUFUSE Anterior Cervical Plate is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping or self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths addressing single level and two levels of fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2 to T1)
Indicated Patient Age Range
skeletally mature patients, skeletally mature adults
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 Test Summary:
The following analyses were conducted:
• Static Axial Compression: Cage per ASTM F2077
• Dynamic Compression: Cage per ASTM F2077
• Static Torsion: Cage per ASTM F2077
• Dynamic Torsion: Cage per ASTM F2077
• Subsidence: Cage per ASTM F2267
• Static Axial Compression: Plate per ASTM F1717
• Dynamic Axial Compression: Plate per ASTM F1717
• Static Torsion: Plate per ASTM F1717
The results of these evaluations indicate that the ACCUFUSE Cervical System is equivalent to predicate devices.
Clinical Test Summary:
No clinical studies were performed
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.
Crystal, Spinal Elements, Inc. (K133218), UNIPLATE Anterior Cervical Plate System, DePuy Spine, Inc. (K042544 / K082273 / K100070), BAK/C Vista Interbody Fusion, Centerpulse Spine-Tech (P980048 S3), CLSP Plate, Synthes, (K000536)
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
August 29, 2018
Absolute Advantage Medical, LLC % Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K181471
Trade/Device Name: ACCUFUSE Cervical System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, KWO Dated: May 31, 2018 Received: June 4, 2018
Dear Mr. Webb:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181471
Device Name ACCUFUSE Cervical System
Indications for Use (Describe)
The ACCUFUSE Cervical System (intervertebral body fusion device) is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACCUFUSE Cervical System implants are placed via an anterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ACCUFUSE Cervical System implants are to be used with supplemental fixation. Patients should have at least six weeks of nonoperative treatment prior to surgery.
The ACCUFUSE Cervical System (cervical plate/screws) is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spimal fusion in patients with:
| •degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), |
|---|
| •spondylolisthesis, |
| •trauma (i.e. fractures or dislocations), |
| •tumors, |
| •deformity (defined as kyphosis, lordosis, or scoliosis), |
| •pseudarthrosis, |
| •failed previous fusion, |
| •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)
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510(k) Summary: ACCUFUSE Cervical System
| Date Prepared | May 31, 2018 |
|---|---|
| Submitted By | Absolute Advantage Medical, LLC |
| 2731 Millbrook Road | |
| Fayetteville, NC 28303 | |
| Primary Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | ACCUFUSE Cervical System |
| Classification Name | Intervertebral Body Fusion Device Spinal Intervertebral body fixation orthosis |
| Common Name | Intervertebral Fusion Device with Bone Graft, Cervical Appliance, Fixation Spinal Intervertebral Body |
| Class | II |
| Product Code | ODP KWQ |
| CFR Section | 21 CFR section 888.3080 21 CFR section 888.3060 |
| Device Panel | Orthopedic |
| Primary Predicate | Crystal, Spinal Elements, Inc. (K133218) |
| Additional Predicate | |
| Devices | UNIPLATE Anterior Cervical Plate System, DePuy Spine, Inc. (K042544 / K082273 / K100070) BAK/C Vista Interbody Fusion, Centerpulse Spine-Tech (P980048 S3) CLSP Plate, Synthes, (K000536) |
| Device Description | The ACCUFUSE Cervical System consists of intervertebral body fusion devices along |
| with cervical plates and screws used to maintain disc space distraction in skeletally | |
| mature adults requiring an intervertebral body fusion. It is designed to be used in | |
| conjunction with supplemental spinal fixation instrumentation. The implant is available in | |
| a range of footprints and heights to suit each individual's pathology and anatomical | |
| conditions of the patient. The implant has a hollow center to allow placement of | |
| autogenous bone graft to promote intervertebral body fusion. Ridges on the superior and | |
| inferior surfaces of the device help to grip the endplates and prevent implant migration | |
| and/or expulsion. | |
| The ACCUFUSE Anterior Cervical Plate is intended for anterior screw fixation of the plate | |
| to the cervical spine. The fixation construct consists of a cervical plate that is attached to | |
| the vertebral body of the cervical spine with self-tapping or self-drilling bone screws using | |
| an anterior approach. Plates are available in a variety of lengths addressing single level | |
| and two levels of fixation. | |
| Materials | PEEK per ASTM F2026 Tantalum per ASTM F560 Titanium alloy (Ti-6Al-4V) per ASTM F136 |
| Intended Use | The ACCUFUSE Cervical System is used to maintain disc space distraction in |
| skeletally mature adults requiring intervertebral body fusion of the cervical spine. | |
| Substantial | |
| Equivalence Claimed to | |
| Predicate Devices | The ACCUFUSE Cervical System is substantially equivalent to the predicate devices |
| in terms of intended use, design, materials used, mechanical safety and performances. | |
| Indications for Use | The ACCUFUSE Cervical System (intervertebral body fusion device) is indicated for use |
| as an intervertebral body fusion device in skeletally mature patients at one or two | |
| contiguous levels of the cervical spine (C2-T1) to facilitate fusion in case of degenerative | |
| disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed | |
| by patient history and radiographic studies. The ACCUFUSE Cervical System implants | |
| are placed via an anterior approach using autogenous bone graft and/or allograft | |
| comprised of cancellous and/or corticocancellous bone graft. The ACCUFUSE Cervical | |
| System implants are to be used with supplemental fixation. Patients should have at least | |
| six weeks of non- operative treatment prior to surgery. | |
| The ACCUFUSE Cervical System (cervical plate/screws) is intended for anterior screw | |
| fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to | |
| fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary | |
| stabilization of the anterior spine during the development of cervical spinal fusion in | |
| patients with: | |
| degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spinal stenosis | |
| Summary of the | |
| technological | |
| characteristics | |
| compared to predicate | Intended Use |
| The ACCUFUSE Cervical System and all the predicates have similar intended uses. | |
| Materials | |
| The ACCUFUSE Cervical System is composed of the same material as the predicate | |
| device | |
| Design Features/Functions | |
| The ACCUFUSE Cervical System and cited predicate devices share similar basic design | |
| features and functions. | |
| Dimensions | |
| The ACCUFUSE Cervical System is dimensionally similar to cited predicate devices. | |
| Sterilization | |
| The ACCUFUSE Cervical System is provided non-sterile and cited predicate devices are | |
| non-sterile for single use only. | |
| Performance Specification | |
| Mechanical testing confirmed the ACCUFUSE Cervical System demonstrated equivalent | |
| performance to the cited predicate device under the same test conditions. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| • Static Axial Compression: Cage per ASTM F2077 | |
| • Dynamic Compression: Cage per ASTM F2077 | |
| • Static Torsion: Cage per ASTM F2077 | |
| • Dynamic Torsion: Cage per ASTM F2077 | |
| • Subsidence: Cage per ASTM F2267 | |
| • Static Axial Compression: Plate per ASTM F1717 | |
| • Dynamic Axial Compression: Plate per ASTM F1717 | |
| • Static Torsion: Plate per ASTM F1717 | |
| The results of these evaluations indicate that the ACCUFUSE Cervical System is | |
| equivalent to predicate devices. | |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non- | |
| clinical and Clinical | Absolute Advantage Medical considers the ACCUFUSE Cervical System to be |
| equivalent to the predicate devices listed above. This conclusion is based upon the | |
| devices' similarities in principles of operation, technology, materials, performance, and | |
| intended use |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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