(130 days)
Not Found
No
The summary describes a physical implant (interbody spacer) and its mechanical properties. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as an "ALTA Anterior Cervical Interbody Spacer" used for "intervertebral body fusion of the spine" in patients with "cervical disc degeneration and/or cervical spinal instability" to address conditions like "radiculopathy, myelopathy, and/or pain." These applications directly refer to treating or alleviating a medical condition, which is the definition of a therapeutic device.
No.
The device is an interbody spacer, an implantable device used in spinal fusion surgery, not a diagnostic device. While its indication for use mentions confirmation by imaging studies (radiographs, CT, MRI), these studies are used to diagnose the patient's condition, not the device itself. The device's purpose is to facilitate fusion, not to diagnose.
No
The device description clearly states it is an implant made of PEEK or titanium, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The ALTA Anterior Cervical Interbody Spacer is an implantable device used in surgery to fuse vertebrae in the cervical spine. It is a physical device inserted into the body, not a tool for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, chemical reactions, or laboratory procedures typically associated with IVDs.
Therefore, the ALTA Anterior Cervical Interbody Spacer is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ALTA Anterior Cervical Interbody Spacer is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ALTA Anterior Cervical Interbody Spacer is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The ALTA Anterior Cervical Interbody Spacer was developed as implants for the stabilization of the cervical column. The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy. This device is offered in PEEK OPTIMA LT120HA. The PEEK OPTIMA LT120HA implants have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants during and after surgery. The titanium implants have roughened superior and inferior surfaces to prevent migration of the spacer post implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT, MRI
Anatomical Site
cervical spine, 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)
The following analyses were conducted:
• Static and dynamic compression per ASTM F2077
• Static and dynamic torsion per ASTM F2077
• Subsidence per ASTM F2267
The results of these evaluations indicate that the PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) ALTA Anterior Cervical Interbody Spacer is equivalent to predicate devices.
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.
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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
February 27, 2018
Astura Medical Mr. Thomas Purcell Vice President 3186 Lionshead Ave, Suite 100 Carlsbad, California 92010
Re: K173324
Trade/Device Name: ALTA Anterior Cervical Interbody Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 10, 2017 Received: December 15, 2017
Dear Mr. Purcell:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
Katherine D. Kavlock -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) K173324
Device Name
ALTA Anterior Cervical Interbody Spacer
Indications for Use (Describe)
The ALTA Anterior Cervical Interbody Spacer is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ALTA Anterior Cervical Interbody Spacer is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate 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) |
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510(k) Summary: ALTA ANTERIOR CERVICAL INTERBODY SPACER
PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced)
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
| Date Prepared | January 31st 2018 |
|---|---|
| Submitted By | Astura Medical |
| 3186 Lionshead Ave, Suite 100 | |
| Carlsbad, CA 92010 | |
| Phone: 760-814-8047 | |
| Contact | Thomas Purcell |
| 3186 Lionshead Ave, Suite 100 | |
| Carlsbad, CA 92010 | |
| Phone: 760-814-8047 | |
| Email: thomas@asturamedical.com | |
| Trade Name | ALTA Anterior Cervical Interbody Spacer |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral Body Fusion Device With Bone Graft, Cervical |
| Class | II |
| Product Code | ODP |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate Device | Astura Medical ALTA Anterior Cervical Interbody Spacer (K160154) |
| Additional Predicate | |
| Device(s) | SpineFrontier Incorporated, Arena-C HA PEEK Cervical Intervertebral Body |
| Fusion Device (K142026), NuVasive® CoRoent® Small Interbody System | |
| (K163491) | |
| Device Description | The ALTA Anterior Cervical Interbody Spacer was developed as implants |
| for the stabilization of the cervical column. The devices have trapezoidal | |
| footprints and multiple sizes to accommodate patient anatomy. This | |
| device is offered in PEEK OPTIMA LT120HA. The PEEK OPTIMA LT120HA | |
| implants have unidirectional teeth on both of their inferior and superior | |
| surfaces to prevent migration/expulsion, and graft windows which help | |
| facilitate bony integration. X-ray markers are integrated for visualization | |
| of the implants during and after surgery. The titanium implants have | |
| roughened superior and inferior surfaces to prevent migration of the | |
| spacer post implantation. | |
| Materials | PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) – MAF 2227 (added |
| material) | |
| Tantalum per ASTM F560 | |
| Substantial Equivalence | |
| Claimed to Predicate | |
| Devices | The PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) ALTA Anterior |
| Cervical Interbody Spacer are substantially equivalent to the predicate | |
| devices in terms of intended use, design, material, and mechanical safety | |
| and performances. | |
| Indications for Use | The ALTA Anterior Cervical Interbody Spacer is indicated for |
| intervertebral body fusion of the spine in skeletally mature patients. The | |
| ALTA Anterior Cervical Interbody Spacer is intended for use for anterior | |
| cervical interbody fusion in patients with cervical disc degeneration | |
| and/or cervical spinal instability, as confirmed by imaging studies | |
| (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or | |
| pain at multiple contiguous levels from C2 - T1. The System is intended to | |
| be used with supplemental fixation. The System is designed for use with | |
| autogenous and/or allogeneic bone graft comprised of cancellous and/or | |
| corticocancellous bone graft to facilitate fusion. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| • Static and dynamic compression per ASTM F2077 | |
| • Static and dynamic torsion per ASTM F2077 | |
| • Subsidence per ASTM F2267 | |
| The results of these evaluations indicate that the PEEK-OPTIMA LT120HA | |
| (PEEK-OPTIMA HA Enhanced) ALTA Anterior Cervical Interbody Spacer is | |
| equivalent to predicate devices. | |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-Clinical | |
| and Clinical | Astura Medical considers the PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA |
| Enhanced) ALTA Anterior Cervical Interbody Spacer 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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