(93 days)
Not Found
No
The summary describes a physical implantable device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an interbody fusion device indicated for the treatment of degenerative disc disease, which involves implanting it to aid in fusion and alleviate pain.
No
The SureMAX-SA™ Cervical Standalone System is described as an interbody fusion device for treating degenerative disc disease, focusing on structural support and fusion, not on diagnosis.
No
The device description clearly states it is a collection of additively manufactured interbody spacers and integrated fixation, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for spinal fusion. It is a physical device implanted into the body to treat a structural issue (degenerative disc disease).
- Device Description: The description details a collection of interbody spacers and integrated fixation, which are physical components for surgical implantation.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function. It is a therapeutic device.
- Performance Studies: The performance studies described are mechanical tests on the physical device, not analytical or clinical performance studies related to diagnostic accuracy.
Therefore, based on the provided information, the SureMAX-SA™ Cervical Standalone System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OVE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, levels C2-T1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of worst case SureMAX-SA TM Cervical Standalone System devices included subsidence, static and dynamic compression, static and dynamic compression shear and static and dynamic torsion according to ASTM F2267 and ASTM F2077. In addition, screw pushout properties were evaluated.
The mechanical test results demonstrate that SureMAX-SA TM Cervical Standalone System performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 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-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 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-SATM Cervical Standalone System is | |
| provided sterile. | |
| Indications for Use: | The SureMAX-SATM 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-SATM 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-SATM 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-SATM Cervical Standalone | |
| System is intended to be used at one level and with supplemental fixation.. | |
| Materials: | SureMAX-SATM Cervical Standalone System interbody implants are |
| manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001. The | |
| fixation 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 Standalone |
| System devices included subsidence, static and dynamic compression, | |
| static and dynamic compression shear and static and dynamic torsion | |
| according to ASTM F2267 and ASTM F2077. In addition, screw pushout | |
| properties were evaluated. | |
| The mechanical test results demonstrate that SureMAX-SATM Cervical | |
| Standalone System performance is substantially equivalent to the predicate | |
| devices. | |
| Technological | |
| Characteristics: | The SureMAX-SATM Cervical Standalone System possesses the same |
| technological characteristics as one or more of the predicate devices. These | |
| include: intended use (as described above), basic design (additively | |
| manufactured structure and integrated fixation), material (titanium alloy) and | |
| sizes (dimensions are comparable to those offered by the predicate | |
| systems). | |
| Therefore the fundamental scientific technology of the SureMAX-SATM | |
| Cervical Standalone System is the same as previously cleared devices. | |
| Conclusion: | The SureMAX-SATM Cervical Standalone System possesses the same |
| intended use and technological characteristics as the predicate devices. | |
| Therefore the SureMAX-SATM Cervical Standalone System is substantially | |
| equivalent for its intended use. |
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