(47 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® open devices incorporate a large vertical cavity which can be packed with bone graft material. The inferior/superior aspects of the NEXXT MATRIXX® solid devices are closed and do not permit the packing of bone graft within the implant. The solid devices are only to be used for partial vertebral body replacement. The open and solid 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 document (K193370) is a 510(k) premarket notification for a medical device called the "Nexxt Matrixx® System," specifically adding an anterior lumbar interbody fusion (ALIF) device. It is not a K medical device submission for an AI/ML-enabled medical device. Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/ML device performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) cannot be extracted from this document because it is not relevant to this type of traditional medical device submission.
The "Performance Data" section in the document states:
"The modified ALIF device was evaluated via dimensional analyses. The results demonstrated the performance of the modified ALIF is substantially equivalent to the predicate."
This indicates that the performance evaluation for this traditional device involved dimensional analyses to demonstrate substantial equivalence to a predicate device, not the kinds of clinical performance studies typically required for AI/ML devices.
Therefore, for your specific request:
- A table of acceptance criteria and the reported device performance: Not applicable in the context of AI/ML performance. The success criterion here is "substantially equivalent" based on dimensional analyses.
- Sample sized used for the test set and the data provenance: Not applicable. Dimensional analyses would involve measuring the device itself, not a patient test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no "ground truth" in the AI/ML sense for a physical implant's dimensional analysis.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. The "ground truth" for a physical device's characteristics would be its specifications and physical measurements.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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January 21, 2020
Nexxt Spine, LLC % Karen E. Warden, PhD President BackRoads Consulting Inc. PO Box 566 Chesterland, Ohio 44026
Re: K193370
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: December 23, 2019 Received: December 26, 2019
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 mediation-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. PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality 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: | 4 December 2019 |
|---|---|
| Sponsor: | Nexxt Spine, LLC14425 Bergen Blvd, Suite BNoblesville, IN 46060Office: 317.436.7801Fax: 317.245.2518 |
| Sponsor Contact: | Andy Elsbury, President |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 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 an anterior lumbar interbody fusion (ALIF) deviceto 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® open devicesincorporate a large vertical cavity which can be packed with bone graftmaterial. The inferior/superior aspects of the NEXXT MATRIXX® soliddevices are closed and do not permit the packing of bone graft within theimplant. The solid devices are only to be used for partial vertebral bodyreplacement. The open and solid devices are available in an assortment ofheight, length, width and lordotic angulation combinations to accommodatethe individual anatomic 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 Ti-6AI-4V ELI titaniumalloy (ASTM F3001). |
| Primary Predicate: | NEXXT MATRIXX® System (Nexxt Spine, LLC - K171140) |
| Additional Predicates: | Cascadia Interbody System (K2M Inc. - K172009) |
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| Performance Data: | The modified ALIF device was evaluated via dimensional analyses. The results demonstrated the performance of the modified ALIF is substantially equivalent to the predicate. |
|---|---|
| TechnologicalCharacteristics: | The modified NEXXT MATRIXX® System ALIF possesses the same technological characteristics as one or more of the predicate devices. 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 NEXXT MATRIXX® System ALIF is the same as previously cleared devices. | |
| Conclusion: | The modified NEXXT MATRIXX® System ALIF possesses the same intended use and technological characteristics as the predicate devices. Therefore the modified NEXXT MATRIXX® System ALIF is substantially equivalent for its intended use. |
§ 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.