BEE Cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of 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 one or two contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE Cages are to be used with autogenous and/or allogeneic 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 two widths, one depth, seven heights, and three lordotic angles.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "BEE Cages" (Cervical Cages), seeking to demonstrate substantial equivalence to a predicate device. It details product information, intended use, and a summary of non-clinical and clinical testing.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Safety	Equivalent or greater strength values compared to predicate and other devices cleared for cervical spine use. Tests performed according to ASTM F2077 and ASTM F2267.
Fusion Development	Lattice structure did not obstruct the development of fusion.

2. Sample Size Used for the Test Set and Data Provenance

The document refers to "non-clinical tests" and "clinical evidence" without specifying explicit test set sample sizes for the mechanical tests or the clinical evidence portion.

Non-clinical (Mechanical) Tests: Performed on the BEE Cervical Cages. The sample size for these specific tests (ASTM F2077, ASTM F2267) is not explicitly stated, but these standards typically involve multiple samples to ensure statistical validity.
Clinical Evidence: The document states that "Clinical evidence was provided to demonstrate that the lattice structure did not obstruct the development of fusion." No details are given regarding the country of origin, whether it was retrospective or prospective, or the number of patients/cases involved in this clinical evidence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The document refers to "clinical evidence" but does not detail how the ground truth for this evidence was established, nor the involvement or qualifications of experts in that process.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned in the document. The document focuses on demonstrating substantial equivalence through non-clinical mechanical testing and general clinical evidence related to fusion, not a comparative analysis of human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical intervertebral body fusion device, not an AI algorithm. Therefore, a standalone algorithm performance study was not conducted.

7. The Type of Ground Truth Used

Non-clinical (Mechanical) Tests: The "ground truth" for the mechanical tests is based on the results obtained from standardized ASTM test methods (ASTM F2077 for intervertebral body fusion devices and ASTM F2267 for measuring load-induced subsidence). The acceptance criteria are implicitly derived from these standards and comparison to predicate device performance.
Clinical Evidence: The ground truth for the "clinical evidence" regarding fusion development is based on clinical outcomes reported in the evidence provided. The exact nature of this outcome data (e.g., imaging reports, surgical reports, patient follow-up) that confirmed fusion is not detailed beyond the statement itself. Pathology or direct outcomes data details are not specified.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical implant, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is a physical medical implant.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 29, 2021

NGMedical GmbH % Christine Scifert Official Correspondent MRC Global 9085 East Mineral Circle, Suite 110 Centennial, Colorado 80112

Re: K200429

Trade/Device Name: BEE Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: January 22, 2021 Received: January 25, 2021

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 (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

{1}------------------------------------------------

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,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K200429

Device Name BEE 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary: BEE Cervical Cages

Date Prepared	January 28, 2021
Submitted By	NGMedical GmbHMorschborn 2866620 NonnweilerGERMANY+49 (0) 6875 91089-0
Primary Contact	Christine ScifertMRC GlobalChristine.scifert@askmrcglobal.com901-831-8053
Trade Name	BEE Cervical Cages
Common Name	Cervical cage
Classification Name	Intervertebral body fusion device - cervical
Class	II
Product Code	ODP
CFR Section	21 CFR section 888.3080
Device Panel	Orthopedic
Primary PredicateDevice	EIT Cellular Titanium® Cervical Cage - EIT Emerging Implant Technologies GmbH(K170503)
Reference PredicateDevices	Crystal® - Spinal Elements, Inc. (K073351)
Device Description	The BEE Cervical Cage is an intervertebral body fusion device for treatment of cervicaldisc degeneration and/or cervical instability utilizing the anterior cervical discectomy andfusion surgical technique. The tapered nose design provides ease of insertion while theconvex superior and flat inferior surfaces replicate the patient's vertebral anatomicalarchitecture for maximum surface contact. The cranial and caudal surfaces have ahoneycomb geometry that accepts packing of bone graft to help facilitate bony integration.The device consists of implants available in two widths, one depth, seven heights, andthree lordotic angles.
Materials	ASTM F136 - Wrought Titanium-6Aluminum-4Vanadium ELIASTM F3001 - ASTM F3001 Additive Manufacturing Titanium-6 Aluminum-4 VanadiumELIASTM F2924 - ASTM F2924 Additive Manufacturing Titanium-6 Aluminum-4 Vanadium
Intended Use	BEE Cervical Cages were developed as an intercorporal implant for the anterior cervicalspondylodesis.
SubstantialEquivalence Claimedto Predicate Devices	The BEE Cervical Cages are substantially equivalent to the predicate devices in termsof intended use, design, materials used, mechanical safety and performances.
Indications for Use	BEE Cages are intended for intervertebral body fusion devices in skeletally mature patientsfor the treatment of cervical disc degeneration and/or cervical spinal instability as confirmedby imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/orpain at one or two contiguous levels from C2-T1. These patients should have had at leastsix weeks of nonoperative treatment. BEE Cages are to be used with autogenous and/orallogeneic bone graft comprised of cancellous and/or corticocancellous bone graft tofacilitate fusion and in combination with supplemental fixation indicated for cervical fusionprocedures.
Summary of thetechnologicalcharacteristicscompared topredicate	Intended UseThe BEE Cervical Cages and the predicate devices are all intended to be used tomaintain adequate disc space until fusion occurs.Indications for UseAll of the devices comply with the indications for use specified in 21 CFR section888.3080 for cervical interbody fusion devices
	MaterialThe BEE Cervical Cage uses the same material as the predicate device.DesignThe BEE Cervical Cage and the predicate are equivalent in terms of shape, material, andmanufacturing process.
	SizesThe BEE Cervical Cage and the predicates are equivalent in their dimensions.StrengthThe BEE Cervical Cage has greater or equivalent strength values compared to otherdevices cleared for use in the cervical spine.
Non-clinical TestSummary	The following analyses were conducted:• ASTM F2077 - Test Methods for Intervertebral Body Fusion Devices• ASTM F2267 - Measuring Load Induced Subsidence of Intervertebral BodyFusion Device Under Static Axial CompressionThe results of these evaluations indicate that the BEE Cervical Cages are equivalent topredicate devices.
Clinical TestSummary	Clinical evidence was provided to demonstrate that the lattice structure did not obstruct thedevelopment of fusion.
Conclusions: Non-clinical and Clinical	NGMedical considers the BEE Cervical Cages to be equivalent to the predicate deviceslisted above. This conclusion is based upon the devices' similarities in principles ofoperation, technology, materials and indications for use.

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

{4}------------------------------------------------

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.