(38 days)
When used as a lumbar intervertebral fusion device, the Nexxt Matrixx® open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of nonoperative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Additionally, the Nexxt Matrixx® lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
The NEXXT MATRIXX® System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7µm). The intervening geometric lattices have pores 300-700µm. The inferior/superior aspects of the NEXXT MATRIXX® ALIF and Lateral devices incorporate a large vertical cavity which can be packed with bone graft material. The devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.
This appears to be an FDA 510(k) summary for a medical device called the "NEXXT MATRIXX® System," which is an intervertebral body fusion device. The document describes the device, its intended use, and the basis for its substantial equivalence to previously marketed devices.
However, the provided text does not contain information about a study that proves the device meets specific acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning algorithm. The "Performance Data" section indicates: "The modified devices were evaluated via dimensional analyses. The results demonstrated the performance of the modified ALIF and Lateral interbody devices to substantially equivalent to the predicate." This refers to physical and mechanical characteristics of the implant, not the performance of an AI system.
Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving an AI device meets those criteria based on this document. The document pertains to a physical medical device (spinal implant), not an AI algorithm.
If you have a different document or would like to ask about other aspects of AI device approval, please provide the relevant information.
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May 21, 2020
Nexxt Spine, LLC % Karen E. Warden, Ph.D. President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026
Re: K200969
Trade/Device Name: NEXXT MATRIXX® System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 1, 2020 Received: May 4, 2020
Dear Dr. Warden:
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 L. Showalter, Ph.D. Assistant Director (Acting) 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name NEXXT MATRIXX® System
Indications for Use (Describe)
When used as a lumbar intervertebral fusion device, the Nexxt Matrixx® open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of nonoperative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Additionally, the Nexxt Matrixx® lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
| 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: | 20 May 2020 |
|---|---|
| Sponsor: | Nexxt Spine, LLC |
| 14425 Bergen Blvd, Suite B | |
| Noblesville, IN 46060 | |
| Office: 317.436.7801 | |
| Fax: 317.245.2518 | |
| Sponsor Contact: | Andy Elsbury, President |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | NEXXT MATRIXX® System |
| Common Name: | Interbody fusion system |
| Device Classification: | Class II |
| Regulation Name,Regulation Number,Product Code: | Intervertebral fusion device with bone graft, lumbar, 888.3080, MAX |
| Submission Purpose: | The subject 510(k) adds modified anterior lumbar interbody fusion (ALIF)and Lateral interbody devices to the NEXXT MATRIXX® System. |
| Device Description: | The NEXXT MATRIXX® System is a collection of additively manufacturedspacers for cervical, lumbar/lumbosacral and thoracolumbar implantation.The basic shape of these implants is a structural column to provide surgicalstabilization of the spine. Each device comprises an external structuralframe having a roughened surface (~7µm). The intervening geometriclattices have pores 300-700µm.The inferior/superior aspects of the NEXXT MATRIXX® ALIF and Lateraldevices incorporate a large vertical cavity which can be packed with bonegraft material. The devices are available in an assortment of height, length,width and lordotic angulation combinations to accommodate the individualanatomic and clinical circumstances of each patient. |
| Indications for Use: | When used as a lumbar intervertebral fusion device, the NEXXT MATRIXX®open devices are indicated for use at one or two contiguous levels in thelumbar spine, from L2-S1, in skeletally mature patients who have had sixmonths of non-operative treatment for the treatment of degenerative discdisease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined asback pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies. Additionally, the NEXXT MATRIXX®lumbar implants can be used as an adjunct to fusion in patients diagnosedwith degenerative scoliosis. The device is intended for use with autograftand/or allograft comprised of cancellous and/or corticocancellous bone graftand with supplemental fixation. |
| Materials: | NEXXT MATRIXX® implants are manufactured from Ti6Al4V ELI titaniumalloy (ASTM F3001). |
| Primary Predicate: | NEXXT MATRIXX® System (Nexxt Spine, LLC – K171140) |
| Additional Predicates: | NEXXT MATRIXX® System (Nexxt Spine, LLC – K192687), NEXXTMATRIXX® System (Nexxt Spine, LLC - K193370) |
| Performance Data: | The modified devices were evaluated via dimensional analyses. The resultsdemonstrated the performance of the modified ALIF and Lateral interbodydevices to substantially equivalent to the predicate. |
| TechnologicalCharacteristics: | The modified NEXXT MATRIXX® System ALIF and Lateral devices possessthe same technological characteristics as one or more of the predicatedevices. These include:• performance (as described above),• basic design (additively manufactured structural interbody),• material (titanium alloy) and• size (dimensions are comparable to those offered by the cleared devices).Therefore the fundamental scientific technology of the modified NEXXTMATRIXX® System devices is the same as previously cleared devices. |
| Conclusion: | The modified NEXXT MATRIXX® System devices possesses the sameintended use and technological characteristics as the predicate devices.Therefore the modified NEXXT MATRIXX® System devices are substantiallyequivalent for their intended use. |
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§ 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.