(30 days)
The SureMAX™ Family of Cervical Spacers is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The SureMAX™ Family of Cervical Spacers is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The SureMAX™ Family of Cervical Spacers is to be used with supplemental fixation; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.
The SureMAX™ Family of Cervical Spacers is an additively manufactured interbody system. These cervical implants have basic keystone shape and an open architecture. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The SureMAX™ Family of Cervical Spacers is provided sterile.
The provided text is a 510(k) Summary for a medical device (SureMAX™ Family of Cervical Spacers) and does not describe an AI/ML-based medical device. Therefore, it does not contain the information needed to answer the questions about acceptance criteria and study proving device performance for an AI/ML device.
The document discusses:
- Device: SureMAX™ Family of Cervical Spacers, an additively manufactured interbody system used for anterior intervertebral body fusion.
- Indication: Treatment of cervical disc degeneration and/or cervical spinal instability.
- Performance Data: Mechanical testing per ASTM F2077 (static and dynamic compression and torsion), ASTM F2267 (subsidence), and expulsion studies.
- Conclusion: The device's performance is substantially equivalent to a predicate device based on these mechanical tests.
The information requested in the prompt, such as acceptance criteria based on accuracy metrics (e.g., sensitivity, specificity), sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not present in this document as it pertains to AI/ML device evaluation.
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January 3, 2020
Additive Implants, Inc. % Karen E. Warden, PhD President BackRoads Consulting, Inc. 12520 Heath Road Chesterland, Ohio 44026
Re: K193359
Trade/Device Name: SureMAXTM Family of Cervical Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 3, 2019 Received: December 4, 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 L. 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)
K193359
Device Name SureMAX™ Family of Cervical Spacers
Indications for Use (Describe)
The SureMAX™ Family of Cervical Spacers is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The SureMAX™ Family of Cervical Spacers is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MR), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The SureMAX™ Family of Cervical Spacers is to be used with supplemental fixation; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.
| 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 December 2019 |
|---|---|
| Sponsor: | Additive Implants, Inc. |
| 3101 E. Shea Blvd, Suite 122 | |
| Phoenix, AZ 85028 | |
| Office: 602.795.8850 | |
| Fax: 602.595.7896 | |
| Sponsor Contact: | Jeff Horn, Vice-President of Commercialization |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | SureMAX™ Family of Cervical Spacers |
| Common Name: | Interbody fusion system |
| Device Classification: | Class II |
| Regulation Name,Regulation Number,Product Code: | Intervertebral fusion device with bone graft, cervical, 888.3080, ODP |
| Submission Purpose: | The subject 510(k) adds a new anterior cervical spacer (SureMAX™-X) tothe SureMAX™ Family of Cervical Spacers. |
| Device Description: | The SureMAX™ Family of Cervical Spacers is an additively manufacturedinterbody system. These cervical implants have basic keystone shape andan open architecture. A variety of height, length, width and anteroposteriorangulation combinations are available to accommodate the anatomicrequirements of individual patients. The SureMAX™ Family of CervicalSpacers is provided sterile. |
| Indications for Use: | The SureMAX™ Family of Cervical Spacers is intended for anteriorintervertebral body fusion in skeletally mature patients who have had atleast six weeks of non-operative treatment. The SureMAX™ Family ofCervical Spacers is indicated to treat cervical disc degeneration and/orcervical spinal instability, as confirmed by imaging studies (radiographs, CT,MRI), that results in radiculopathy, myelopathy, and/or pain at multiplecontiguous levels from C2 - T1. The SureMAX™ Family of Cervical Spacersis to be used with supplemental fixation; the hyperlordotic implants (≥10°)are required to be used with an anterior cervical plate. The implants aredesigned for use with autogenous and/or allogeneic bone graft comprised ofcancellous and/or corticocancellous bone to facilitate fusion. |
| Materials: | The SureMAX™ Family of Cervical Spacers is manufactured from Ti-6Al-4VELI titanium alloy (ASTM F3001, Grade 23). |
| Primary Predicate: | Cervical Spacer (Additive Implants, LLC - K182477) |
| Additional Predicates: | Cascadia Interbody System (K2M Inc. – K160125), Aleutian IBF System(K2M Inc. - K082698) |
| Performance Data: | The modified SureMAX™-X cervical spacer was evaluated via mechanicaltesting per ASTM F2077 (including static and dynamic compression andstatic and dynamic torsion), ASTM F2267 (subsidence) and expulsion. Theresults demonstrated the performance of the modified cervical spacer issubstantially equivalent to the predicate. |
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| TechnologicalCharacteristics: | The modified SureMAX™-X cervical spacer possesses the sametechnological characteristics as one or more of the predicate devices. Theseinclude:• performance (as described above),• basic design (additively manufactured structural interbody),• material (titanium alloy) and• size (dimensions are comparable to those offered by the cleareddevices).Therefore the fundamental scientific technology of the modifiedSureMAX™-X cervical spacer is the same as previously cleared devices. |
|---|---|
| Conclusion: | The modified SureMAX™-X cervical spacer possesses the same intendeduse and technological characteristics as the predicate devices. Thereforethe modified SureMAX™-X cervical spacer is substantially equivalent for itsintended 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.