(268 days)
No
The summary describes a physical implant (interbody fusion device) and its materials, intended use, and performance testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device, an intervertebral body fusion system, is used to treat degenerative disc disease and facilitate fusion in the spine, which falls under the definition of a therapeutic device.
No
This device is an intervertebral body fusion device used to improve stability of the spine and facilitate fusion; it does not diagnose medical conditions.
No
The device description explicitly states the device is an implantable intervertebral body fusion device made of titanium alloy, which is a physical hardware component.
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 description clearly states that the Align Cervical Interbody Fusion System is an implantable device used for spinal fusion. It is surgically placed within the body to stabilize the spine and facilitate bone growth.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, the Align Cervical Interbody Fusion System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Align Cervical Interbody Fusion is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. The Align Cervical Interbody Fusion System is intended for use at either one level or two contiguous levels in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Align Cervical Interbody Fusion is intended to be used with supplemental spinal fixation system cleared for use in the cervical spine.
Product codes
ODP
Device Description
The Align Cervical Interbody Fusion System consists of intervertebral body fusion devices that are implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion. Components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy. Align cervical cages will be manufactured from titanium alloy per ASTM F3001 and will be offered with an optional hydroxyapatite (HA) coating. Implants will be provided sterile by gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, from C2 to 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)
Confirmatory fatigue testing (dynamic compression shear, and dynamic torsion per ASTM F2077) has been performed on the subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The Department of Health & Human Services seal is a stylized representation of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square.
December 1, 2023
Acuity Surgical Devices, LLC % Ms. Christine Scifert Partner MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial, Colorado 80112
Re: K230639
Trade/Device Name: Align Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: October 31, 2023 Received: November 1, 2023
Dear Ms. Christine Scifert:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S
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
2
Indications for Use
510(k) Number (if known)
K230639
Device Name Align Cervical Interbody Fusion System
Indications for Use (Describe)
The Align Cervical Interbody Fusion is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. The Align Cervical Interbody Fusion System is intended for use at either one level or two contiguous levels in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Align Cervical Interbody Fusion is intended to be used with supplemental spinal fixation system cleared for use in the cervical spine.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary Align Cervical Interbody Fusion System 31 October 23
| Company: | Acuity Surgical Devices, LLC
8710 N. Royal Lane
Irving, TX 75063
(844) 228-4890 |
|-------------------------|-------------------------------------------------------------------------------------------|
| Company Contact: | Bryan Cowan
President
(844) 228-4890
BCowan@AcuitySurgical.com |
| Official Correspondent: | Christine Scifert – MRC Global, LLC
Christine.scifert@askmrcglobal.com
901-831-8053 |
| Trade Name: | Align Cervical Interbody Fusion System |
| Common Name: | Intervertebral fusion device with bone graft, cervical |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3080 (Intervertebral body fusion device) |
| Panel: | Orthopedic |
| Product Code: | ODP |
Device Description:
The Align Cervical Interbody Fusion System consists of intervertebral body fusion devices that are implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion. Components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy. Align cervical cages will be manufactured from titanium alloy per ASTM F3001 and will be offered with an optional hydroxyapatite (HA) coating. Implants will be provided sterile by gamma irradiation.
Indications for Use:
The Align Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six weeks of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. The Align Cervical Interbody Fusion System is intended for use at either one level or two contiguous levels in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Align Cervical Interbody Fusion System is intended to be used
4
with supplemental spinal fixation system cleared for use in the cervical spine.
Substantial Equivalence:
The subject Align Cervical Interbody System is substantially equivalent to the following predicate devices:
Primary Predicate:
-
. Aurora Spine Interbody Fusion System – K133967
Secondary Predicate: -
Alphatec Spine, Inc. IdenitTi™ Porous Ti Interbody System K183705 .
Reference Device:
- Acuity Align Lumbar Interbody Fusion System K222561 .
There are insignificant differences between the subject Align Cervical Interbody System and the predicates. The Indications for Use, Materials, and Geometry for predicate devices are all inclusive of the subject device. Performance analysis shows that the subject Align Cervical Interbody System does not introduce a new worst case and is expected to perform as well as or better than the predicate devices. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.
Performance Testing:
Confirmatory fatigue testing (dynamic compression shear, and dynamic torsion per ASTM F2077) has been performed on the subject devices.
Conclusion:
Based on the performance analysis and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.