(91 days)
No
The 510(k) summary describes a mechanical interbody spacer and stabilization system for cervical spine fusion. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
This device is an intervertebral body fusion device (spacer and plate assembly) designed to stabilize the cervical column, not to provide therapy or treatment for a disease. Its purpose is to facilitate bone fusion after the diseased disc is removed.
No
The device is an implantable intervertebral body fusion device used to facilitate fusion, not to diagnose a condition.
No
The device description clearly states it is comprised of physical implants (spacers and plates made of PEEK and Titanium alloy) intended for surgical implantation. It does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a cervical interbody spacer) intended for use within the human body to facilitate bone fusion in the cervical spine. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
The information provided focuses on the mechanical properties, surgical application, and intended anatomical placement of the device, all of which are characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The DOLOMITE Stand-Alone Cervical Interbody Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six weeks of nonoperative treatment with intervertebral cages. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Dolomite Spacer is an interbody fusion device intended to be used with supplemental fixation for one or two levels of the cervical spine.
The DOLOMITE Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use at one or two levels of the cervical spine (C2-T1) and used with titanium alloy screws. Multiple full plate assembly configurations can't be used in conjunction for two contiguous levels of the cervical spine. When used with anchors, the assembly is intended for use at one level of the cervical spine with additional supplemental fixation that has been cleared by the FDA for use in the cervical spine.
The DOLOMITE Stand-Alone Cervical Interbody Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six weeks of nonoperative treatment prior to treatment with intervertebral cages. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Dolomite Spacer is an interbody fusion device intended to be used with supplemental fixation for one or two levels of the cervical spine.
The DOLOMITE Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use at one or two levels of the cervical spine (C2-T1) and used with titanium alloy screws. Multiple full plate assembly configurations can't be used in conjunction for two contiguous levels of the cervical spine. When used with anchors, the assembly is intended for use at one level of the cervical spine with additional supplemental fixation that has been cleared by the FDA for use in the cervical spine.
Product codes (comma separated list FDA assigned to the subject device)
OVE, ODP
Device Description
The DOLOMITE Anterior Cervical Stabilization System are implants developed for the stabilization of the cervical column. The spacers are a 2-piece modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a locking mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights in PEEK OPTIMA LT120HA or machined Titanium alloy. The plates are offered in multiple fixation types and sizes to suit the individual pathology and anatomical conditions of the patient in machined Titanium alloy. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates to allow bone growth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at disc levels (C2-T1)
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)
Non-clinical tests: Dynamic Compression, Static Compression, Dynamic Torsion, Static Torsion. The results indicate that the Dolomite implants are equivalent to predicate devices.
Clinical studies: 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.
Astura Medical ALTA Anterior Cervical Interbody Spacer (K160154)
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.
Globus COALITION Spacer (K173115), Globus HEDRON Cervical Spacer (K191243), LDR Spine Cervical Interbody Fusion System (K091088)
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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October 26, 2020
Astura Medical, LLC Mr. Parker Kelch Quality Manager 4949 W Royal Ln. Irving, Texas 75063
Re: K202065
Trade/Device Name: DOLOMITE Anterior Cervical Stabilization System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: July 23, 2020 Received: July 27, 2020
Dear Mr. Kelch:
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
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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 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,
Brent Showalter, Ph.D. 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)
K202065
Device Name DOLOMITE Anterior Cervical Stabilization System
Indications for Use (Describe)
The DOLOMITE Stand-Alone Cervical Interbody Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six weeks of nonoperative treatment with intervertebral cages. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Dolomite Spacer is an interbody fusion device intended to be used with supplemental fixation for one or two levels of the cervical spine.
The DOLOMITE Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use at one or two levels of the cervical spine (C2-T1) and used with titanium alloy screws. Multiple full plate assembly configurations can't be used in conjunction for two contiguous levels of the cervical spine. When used with anchors, the assembly is intended for use at one level of the cervical spine with additional supplemental fixation that has been cleared by the FDA for use in the cervical spine.
| 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) |
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510(k) Summary
| Date Prepared | June 26, 2020 |
|---|---|
| Submitted By | Astura Medical |
| 4949 W Royal Ln | |
| Irving, TX 75063 | |
| Phone: 469-501-5530 | |
| Contact | Parker Kelch |
| Email: quality@asturamedical.com | |
| Trade Name | DOLOMITE Anterior Cervical Stabilization System |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - cervical |
| Class | II |
| Product Code | OVE, ODP |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Astura Medical ALTA Anterior Cervical Interbody Spacer (K160154) |
| Secondary Predicate | |
| Device | Globus COALITION Spacer (K173115); Globus HEDRON Cervical Spacer |
| (K191243); LDR Spine Cervical Interbody Fusion System (K091088) | |
| Device Description | The DOLOMITE Anterior Cervical Stabilization System are implants developed |
| for the stabilization of the cervical column. The spacers are a 2-piece modular | |
| design which allows for interchangeable plate and spacer components. The | |
| plate and spacer components contain interlocking features in addition to a | |
| locking mechanism which allows for intraoperative assembly prior to | |
| implantation. The spacer components are available in a range of footprints and | |
| heights in PEEK OPTIMA LT120HA or machined Titanium alloy. The plates are | |
| offered in multiple fixation types and sizes to suit the individual pathology and | |
| anatomical conditions of the patient in machined Titanium alloy. The implants | |
| have a hollow center to allow placement of autogenous bone graft. The | |
| superior and inferior surfaces are open to promote contact of the bone graft | |
| with the vertebral end plates to allow bone growth. | |
| Materials | PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) |
| Tantalum per ASTM F560 | |
| Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 | |
| Nitinol #1 (ASTM F2063) | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The DOLOMITE Stand-Alone Cervical System is substantially equivalent to the |
| predicate devices in terms of intended use, design, materials | |
| used, mechanical safety and performance. | |
| Indications for Use | The DOLOMITE Stand-Alone Cervical Interbody Spacer is indicated for |
| intervertebral body fusion procedures in skeletally mature patients with | |
| degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). | |
| Cervical degenerative disc disease is defined as neck pain of discogenic origin | |
| with degeneration of the disc confirmed by history and radiographic studies. | |
| Patients should have at least six weeks of nonoperative treatment prior to | |
| treatment with intervertebral cages. The System is designed for use with | |
| autogenous and/or allogeneic bone graft comprised of cancellous and/or | |
| corticocancellous bone graft to facilitate fusion. | |
| The Dolomite Spacer is an interbody fusion device intended to be used with | |
| supplemental fixation for one or two levels of the cervical spine. |
The DOLOMITE Spacer and Plate assembly are an integrated interbody fusion
device intended for stand-alone use at one or two levels of the cervical spine
(C2-T1) and used with titanium alloy screws. Multiple full plate assembly
configurations can't be used in conjunction for two contiguous levels of the
cervical spine. When used with anchors, the assembly is intended for use at
one level of the cervical spine with additional supplemental fixation that has
been cleared by the FDA for use in the cervical spine. |
| Non-clinical Test
Summary | The following analyses were conducted:
Dynamic Compression Static Compression Dynamic Torsion Static Torsion The results of these evaluations indicate that the Dolomite implants
are equivalent to predicate devices. |
| Clinical Test
Summary | No clinical studies were performed |
| Conclusions: Non-
Clinical and Clinical | Astura Medical considers DOLOMITE Anterior Cervical Stabilization System to
be equivalent to the predicate devices listed above. This conclusion is based
upon the devices' similarities in principles of operation, technology, materials
and indications for use. |
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