(93 days)
The SureMAX-SA™ Cervical Standalone System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients as an adjunct to fusion for the treatment of degenerative disc disease (DDD). DDD is defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with the device. The SureMAX-SA™ Cervical Standalone System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. When used with the fixed or variable screws, the SureMAX-SA™ Cervical Standalone System is intended to be used at one or two levels from C2-T1 and requires no additional fixation. When used with one or more helical screws, the SureMAX-SA™ Cervical Standalone System is intended to be used at one level and with supplemental fixation.
The SureMAX-SA™ Cervical Standalone System is a collection of additively manufactured interbody spacers and integrated fixation for cervical implantation The cervical spacers have basic rounded rectangular shape and an open architecture. The integrated fixation consists of three screw options. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The SureMAX-SA™ Cervical Standalone System is provided sterile.
The provided text describes a 510(k) premarket notification for the SureMAX-SA™ Cervical Standalone System, an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing details about an AI-based system's acceptance criteria and a study proving its performance against those criteria.
Therefore, I cannot provide the requested information as the input document does not contain details about:
- Acceptance criteria for an AI-based device's performance.
- A study proving an AI device meets acceptance criteria.
- Sample sizes for test sets where AI performance would be evaluated.
- Data provenance, expert involvement, or adjudication methods for AI ground truth.
- MRMC studies or standalone AI performance.
- Training set details for an AI model.
The document describes the device's mechanical testing to show substantial equivalence to predicate devices, which is common for physical medical devices, but it does not involve any AI performance evaluation.
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July 16, 2021
Additive Implants, Inc % Karen Warden, PhD President BackRoads Consulting 12520 Heath Road Chesterland, Ohio 44026
Re: K211111
Trade/Device Name: SureMAX-SATM Cervical Standalone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: June 11, 2021 Received: June 14, 2021
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.
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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) 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.
for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K211111
Device Name
SureMAX-SA™ Cervical Standalone System
Indications for Use (Describe)
The SureMAX-SA™ Cervical Standalone System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients as an adjunct to fusion for the treatment of degenerative disc disease (DDD). DDD is defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment with the device. The SureMAX-SA™ Cervical Standalone System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. When used with the fixed or variable screws, the SureMAX-SA™ Cervical Standalone System is intended to be used at one or two levels from C2-T1 and requires no additional fixation. When used with one or more helical screws, the SureMAX-SA™ Cervical Standalone System is intended to be used at one level 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: | 9 June 2021 |
|---|---|
| Sponsor: | Additive Implants, Inc.3101 E. Shea Blvd, Suite 122Phoenix, AZ 85028Office: 602.795.8850Fax: 602.595.7896 |
| Sponsor Contact: | Jeff Horn, Vice-President of Commercialization |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457 |
| Proposed Trade Name: | SureMAX-SATM Cervical Standalone System |
| Common Name: | Interbody fusion system |
| Device Classification: | Class II |
| Regulation Name, Regulation Number, Product Code: | Intervertebral fusion device, 888.3080, OVE |
| Device Description: | The SureMAX-SATM Cervical Standalone System is a collection of additivelymanufactured interbody spacers and integrated fixation for cervicalimplantation The cervical spacers have basic rounded rectangular shapeand an open architecture. The integrated fixation consists of three screwoptions. A variety of height, length, width and anteroposterior angulationcombinations are available to accommodate the anatomic requirements ofindividual patients. The SureMAX-SATM Cervical Standalone System isprovided sterile. |
| Indications for Use: | The SureMAX-SATM Cervical Standalone System is a stand-alone anteriorcervical interbody fusion device indicated for use in skeletally maturepatients as an adjunct to fusion for the treatment of degenerative discdisease (DDD). DDD is defined as discogenic neck pain with degenerationof the disc confirmed by history and radiographic studies. These patientsshould have had six weeks of non-operative treatment prior to treatmentwith the device. The SureMAX-SATM Cervical Standalone System is to beused with autograft bone graft and/or allogeneic bone graft composed ofcancellous and/or corticocancellous bone and implanted via an open,anterior approach. When used with the fixed or variable screws, theSureMAX-SATM Cervical Standalone System is intended to be used at oneor two levels from C2-T1 and requires no additional fixation. When usedwith one or more helical screws, the SureMAX-SATM Cervical StandaloneSystem is intended to be used at one level and with supplemental fixation.. |
| Materials: | SureMAX-SATM Cervical Standalone System interbody implants aremanufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001. Thefixation screws and locking cam subcomponents are manufactured from Ti-6Al-4V ELI titanium alloy per F136. |
| Primary Predicate: | COALITION MISTM Spacer, Globus Medical, Inc. - K151939 |
| Additional Predicate: | Hexanium® ACIF, SpineVision SAS – K193000 |
| Performance Data: | Mechanical testing of worst case SureMAX-SA TM Cervical StandaloneSystem devices included subsidence, static and dynamic compression,static and dynamic compression shear and static and dynamic torsionaccording to ASTM F2267 and ASTM F2077. In addition, screw pushoutproperties were evaluated.The mechanical test results demonstrate that SureMAX-SATM CervicalStandalone System performance is substantially equivalent to the predicatedevices. |
| TechnologicalCharacteristics: | The SureMAX-SATM Cervical Standalone System possesses the sametechnological characteristics as one or more of the predicate devices. Theseinclude: intended use (as described above), basic design (additivelymanufactured structure and integrated fixation), material (titanium alloy) andsizes (dimensions are comparable to those offered by the predicatesystems).Therefore the fundamental scientific technology of the SureMAX-SATMCervical Standalone System is the same as previously cleared devices. |
| Conclusion: | The SureMAX-SATM Cervical Standalone System possesses the sameintended use and technological characteristics as the predicate devices.Therefore the SureMAX-SATM Cervical Standalone System is substantiallyequivalent 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.