BEE Cervical Cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE Cervical Cages are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

Device Description

The BEE Cervical Cage is an intervertebral body fusion device for treatment of cervical disc degeneration and/or cervical instability utilizing the anterior cervical discectomy and fusion surgical technique. The tapered nose design provides ease of insertion while the convex superior and flat inferior surfaces replicate the patient's vertebral anatomical architecture for maximum surface contact. The cranial and caudal surfaces have a honeycomb geometry that accepts packing of bone graft to help facilitate bony integration. The device consists of implants available in various sizes and configurations to be accommodate for varying patient anatomy. The BEE Cervical Cages are fabricated using a Direct Metal Printing (DMP) via additive manufacturing (AM) process using Ti-6Al-4V ELI powder.

AI/ML Overview

The provided text describes the regulatory clearance (K231371) for the BEE Cervical Cage, a medical device used for intervertebral body fusion. It outlines the device's indications for use, its technical specifications, and the rationale for its substantial equivalence to previously cleared devices.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document primarily focuses on mechanical performance testing for the device. The reported performance is that the devices met the predefined acceptance criteria for each test. Specific numerical results are not provided in this regulatory summary.

Acceptance Criteria	Reported Device Performance
Original Clearance (K200429):
Compression per ASTM 2077-18	Met predefined acceptance criteria.
Compression shear per ASTM 2077-18	Met predefined acceptance criteria.
Torsion per ASTM 2077-18	Met predefined acceptance criteria.
Subsidence per ASTM 2267-04	Met predefined acceptance criteria.
Expulsion per ASTM 2267-04	Met predefined acceptance criteria.
Subject Device (K231371 - Size Expansion):
Dynamic compression shear per ASTM 2077-18	Results met the predefined acceptance criteria.
Subsidence per ASTM 2267-04	Results met the predefined acceptance criteria.

2. Sample sized used for the test set and the data provenance

The document does not specify the sample sizes (number of devices) used for each mechanical test. The "test set" in this context refers to the physical devices subjected to mechanical testing, not a dataset for an AI algorithm. The provenance of the data is from performance testing conducted by NGMedical GmbH. It is a retrospective evaluation of a device, where the testing is performed to demonstrate substantial equivalence to previously cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to the provided document. The "ground truth" for this device is established through mechanical engineering standards (ASTM standards) and a comparison to predicate devices, not through expert human interpretation of data like in an AI/imaging study.

4. Adjudication method for the test set

This question is not applicable. Mechanical testing against industry standards (ASTM) does not involve adjudication methods like those used for expert consensus in medical image interpretation. The outcome is determined by whether the device meets the specified mechanical thresholds.

5. 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

This is not applicable. The device is a physical intervertebral fusion cage, not an AI or imaging diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this device's clearance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a physical medical implant, not an AI algorithm.

7. The type of ground truth used

The ground truth used for this device is based on established mechanical engineering standards (ASTM) and a comparison to the performance of predicate devices. The device's safety and effectiveness are inferred by its ability to meet these standards and demonstrate substantial equivalence in design and performance to devices already cleared for market.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a physical medical device. The device's design is based on engineering principles and previous successful designs, not on machine learning training data.

9. How the ground truth for the training set was established

This is not applicable as there is no training set for this type of device.

Summary

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January 12, 2024

NGMedical GmbH % Christine Scifert Partner MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial, Colorado 80112

Re: K231371

Trade/Device Name: BEE Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 20, 2023 Received: December 20, 2023

Dear Christine Scifert:

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.

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).

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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 OS 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.

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-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 -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

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Indications for Use

510(k) Number (if known)

K231371

Device Name BEE Cervical Cage

Indications for Use (Describe)

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 BEE Cervical Cages – K231371 September 26, 2023

Company:	NGMedical GmbHTrierer Strasse 65Nonnweiler DE 66620+49 6873 99997-100
Company Contact:	Stella Hahn – Head of Regulatory Affairs+49 6873 99997-100
Official Correspondent:	Christine Scifert - MRC Global, LLCChristine.scifert@askmrcglobal.com901-831-8053
Trade Name:	BEE Cervical Cages
Common Name:	Intervertebral Fusion Device With Bone Graft, Cervical
Classification:	Class II
Regulation Number:	21 CFR 888.3080 (Intervertebral body fusion device)
Panel:	Orthopedic
Product Code:	ODP

Device Description:

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Indications for Use:

Substantial Equivalence:

The subject components are substantially equivalent to the following predicate devices:

Primary Predicate:

BEE Cervical Cages, NGMedical GmbH, K200429 ●

Secondary Predicate:

o uCerv Flux™-C 3D Porous Titanium Cervical Interbody, Ulrich medical USA, Inc, K220696
The subject components indications, technological characteristics and materials are identical to the primary predicate. The secondary predicate has been included to show that the geometry of the expanded sizes of the subject device fall within the size range of the secondary predicate.

Performance Testing:

The following performance testing was conducted for the original clearance of the BEE Cervical Cage System (K200429):

Compression per ASTM 2077-18
Compression shear per ASTM 2077-18
Torsion per ASTM 2077-18
. Subsidence per ASTM 2267-04
. Expulsion per ASTM 2267-04

The following mechanical testing was repeated for the subject device to confirm that the size range expansion does not affect the performance of the system:

Dynamic compression shear per ASTM 2077-18
Subsidence per ASTM 2267-04

Results of both tests met the predefined acceptance criteria. The BEE cervical cage range extension is substantially equivalent to the original device.

Conclusion:

Based on the finite element analysis and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.