(93 days)
The Adaptix™ PEEK Interbody System with Nanotechnology devices and the Capstone Control™ PEEK Spinal System with Nanotechnology devices including those with macro-, micro- and nano-roughened surface textures are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s).
Additionally, Adaptix™ PEEK Interbody System with Nanotechnology and the Capstone Control™ PEEK Spinal System with Nanotechnology devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Adaptix™ PEEK and the Capstone Control™ PEEK devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures and may be implanted via an open or a minimally invasive posterior approach and/or transforaminal approach.
The Adaptix™ PEEK Interbody System with Nanotechnology and Capstone Control™ PEEK Spinal System with Nanotechnology consist of interbody implants designed for restoration of sagittal alignment in the lumbar spine. The upper and lower surfaces of the implant incorporate a three-dimensional titanium scaffold with interconnected pores averaging 523 μm, and pore interconnections averaging 229 μm in diameter. This product demonstrates the requirements for nanotechnology. The surface has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. The scaffold of the Adaptix™ PEEK and Capstone Control™ PEEK devices is electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers. Calcium and phosphate are incorporated into the nanotube surface. The scaffold with nanotubes assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. The Adaptix™ PEEK and Capstone Control™ PEEK devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.
The provided text describes a medical device, the Adaptix™ PEEK Interbody System with Nanotechnology and Capstone Control™ PEEK Spinal System with Nanotechnology, and its 510(k) submission for substantial equivalence to predicate devices. It does not present acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered medical device.
The "Performance Data" section solely discusses mechanical and MR compatibility testing, which are standard for interbody fusion devices and not related to AI/ML performance.
Therefore, I cannot extract the requested information about acceptance criteria and a study proving their fulfillment for an AI/ML device from the given document. The document pertains to a physical medical implant, not an AI/ML software.
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September 5, 2024
Nanovis LLC % Karen Warden, Ph.D. President BackRoads Consulting Inc. PO Box 566 Chesterland, Ohio 44026
Re: K241605
Trade/Device Name: Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 6, 2024 Received: August 6, 2024
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 (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.
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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).
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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
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assistance/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
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Adaptix ™ PEEK Interbody System with Nanotechnology;
Capstone Control™ PEEK Spinal System with Nanotechnology
Indications for Use (Describe)
The Adaptix™ PEEK Interbody System with Nanotechnology devices and the Capstone Control™ PEEK Spinal System with Nanotechnology devices including those with macro-, micro- and nanoroughened surface textures are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s).
Additionally, Adaptix™ PEEK Interbody System with Nanotechnology and the Capstone Control™ PEEK Spinal System with Nanotechnology devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Adaptix™ PEEK and the Capstone Control™ PEEK devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures and may be implanted via an open or a minimally invasive posterior approach and/or transforaminal approach.
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: | 3 June 2024 |
|---|---|
| Sponsor: | Nanovis Spine, LLC5865 East State Rd. 14Columbia City, Indiana 46725 USA(877) 907-6266(260) 625-3834 |
| Sponsor Contact: | Brian More, CEO |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457 |
| Proposed TradeNames: | Adaptix™ PEEK Interbody System with Nanotechnology and CapstoneControl™ PEEK Spinal System with Nanotechnology |
| Common Name: | Lumbar interbody fusion device |
| Device Classification: | Class II |
| Classification Name,Regulation Number,Product Code: | Intervertebral fusion device with bone graft, lumbar, 888.3080, MAX |
| Device Description: | The Adaptix™ PEEK Interbody System with Nanotechnology and CapstoneControl™ PEEK Spinal System with Nanotechnology consist of interbodyimplants designed for restoration of sagittal alignment in the lumbar spine. Theupper and lower surfaces of the implant incorporate a three-dimensionaltitanium scaffold with interconnected pores averaging 523 μm, and poreinterconnections averaging 229 μm in diameter.This product demonstrates the requirements for nanotechnology. The surfacehas been deliberately manipulated to produce nanoscale dimensions whichexhibit specific properties. The scaffold of the Adaptix™ PEEK and CapstoneControl™ PEEK devices is electrochemically treated to possess a controllednanotopography composed of nanotube arrays having a pore size diameterbetween 30-90 nanometers. Calcium and phosphate are incorporated into thenanotube surface. The scaffold with nanotubes assists in securing the implantin the intervertebral space and provides radiographic confirmation of theimplant location.The Adaptix™ PEEK and Capstone Control™ PEEK devices are available in avariety of sizes to accommodate the individual anatomic and clinicalcircumstances of each patient. |
| Indications for Use: | The Adaptix™ PEEK Interbody System with Nanotechnology devices and theCapstone Control™ PEEK Spinal System with Nanotechnology devicesincluding those with macro-, micro- and nano-roughened surface texturedfeatures are intended for spinal fusion procedures in skeletally mature patientswith degenerative disc disease (defined as discogenic back pain withdegeneration of the disc confirmed by history and radiographic studies) at oneor two contiguous spinal levels from L2-S1. These patients should have hadsix months of nonoperative treatment. These patients may have had aprevious non-fusion spinal surgery and/or may have up to Grade 1spondylolisthesis or retrolisthesis at the involved spinal level(s).Additionally, Adaptix™ PEEK Interbody System with Nanotechnology and theCapstone Control™ PEEK Spinal System with Nanotechnology devices can |
| be used as an adjunct to fusion in patients diagnosed with degenerativescoliosis. The Adaptix™ PEEK and the Capstone Control™ PEEK devices areto be used with autograft and/or allograft comprised of cancellous and/orcorticocancellous bone graft and/or demineralized allograft bone with bonemarrow aspirate. These implants are intended for use with supplementalfixation indicated for lumbar spinal fusion procedures and may be implantedvia an open or a minimally invasive posterior approach and/or transforaminalapproach. | |
| Materials: | The Adaptix™ PEEK and Capstone Control™ PEEK implants aremanufactured from polyetheretherketone (PEEK-OPTIMA® LT1) per ASTMF2026. The integral scaffold (OsteoSync) is manufactured from CP titanium(Grade 2) as described by ASTM F67. Marker pins in these lumbar devicesare manufactured from tantalum per ASTM F560. |
| Primary Predicate: | Nano FortiCore® (Nanovis, LLC – K191822) |
| Additional Predicate: | Cascadia Interbody System (K2M, Inc. – K172009), Lumbar I/F Cage® (DePuyAcroMed Inc. - P960025), Capstone Control™ Spinal System (MedtronicSofamor Danek USA, Inc. – K190165), Adaptix™ Interbody System with TitannanoLOCK Surface Technology (Medtronic Sofamor Danek USA, Inc. –K201267) |
| Performance Data: | Mechanical testing of the worst case Adaptix™ PEEK and Capstone Control™PEEK implants included static and dynamic axial compression and static anddynamic compression shear according to ASTM F2077. In addition,subsidence tests according to ASTM F2267 and expulsion tests wereperformed.The mechanical test results demonstrate that the Adaptix™ PEEK andCapstone Control™ PEEK performance is substantially equivalent to thepredicate devices.Additionally, MR Compatibility testing per ASTM F2503 was performed. Theresults demonstrate that the Adaptix™ PEEK and Capstone Control™ PEEKimplants can be safely scanned in an MR system. |
| TechnologicalCharacteristics: | The Adaptix™ PEEK Interbody System with Nanotechnology and CapstoneControl™ PEEK Spinal System with Nanotechnology possess the sametechnological characteristics as one or more of the predicate devices. Theseinclude:● basic design (structural column),● material (reinforced polymer) and● sizes (comparable to those offered by the predicates) |
| Conclusion: | Therefore the fundamental scientific technology of the Adaptix™ PEEKInterbody System with Nanotechnology and Capstone Control™ PEEK SpinalSystem with Nanotechnology is the same as previously cleared devices.The Adaptix™ PEEK Interbody System with Nanotechnology and CapstoneControl™ PEEK Spinal System with Nanotechnology implants possess thesame intended use and technological characteristics as the predicate devices.Therefore Adaptix™ PEEK Interbody System with Nanotechnology andCapstone Control™ PEEK Spinal System with Nanotechnology aresubstantially equivalent for its 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.