Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a physical implant (a cervical cage) and its mechanical properties and intended use. There is no mention of software, algorithms, or any technology that would involve AI or ML for image analysis, diagnosis, or treatment planning. The device is a passive implant.

Therapeutic

Yes
A therapeutic device is used to treat or alleviate a disease or condition. This device is intended for the treatment of cervical disc degeneration and/or cervical spinal instability.

Diagnostic

No

Explanation: The device is an intervertebral body fusion device used for treatment, not for diagnosing medical conditions. It is used in conjunction with imaging studies (radiographs, CT, MRI) which are diagnostic tools, but the device itself does not perform diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical implant (intervertebral body fusion device) made of material with specific dimensions and geometry, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
Device Function: The BEE Cages are implants designed to be surgically inserted into the cervical spine to facilitate fusion and provide stability. They are a physical device used in the body, not a test performed on a sample from the body.
Intended Use: The intended use clearly describes a surgical procedure for treating cervical disc degeneration and instability, not a diagnostic test.
Device Description: The description details the physical characteristics and design of the implant.

Therefore, the BEE Cages fall under the category of a surgical implant or medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

ODP

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

radiographs, CT, MRI

Anatomical Site

cervical disc (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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Test Summary:
The following analyses were conducted:
• ASTM F2077 - Test Methods for Intervertebral Body Fusion Devices
• ASTM F2267 - Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

The results of these evaluations indicate that the BEE Cervical Cages are equivalent to predicate devices.

Clinical Test Summary:
Clinical evidence was provided to demonstrate that the lattice structure did not obstruct the development of fusion.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K170503

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K073351

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K200429

Device Name BEE Cage

Indications for Use (Describe)

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.

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

Date Prepared	January 28, 2021
Submitted By	NGMedical GmbH
Morschborn 28
66620 Nonnweiler
GERMANY
+49 (0) 6875 91089-0
Primary Contact	Christine Scifert
MRC Global
Christine.scifert@askmrcglobal.com
901-831-8053
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 Predicate
Device	EIT Cellular Titanium® Cervical Cage - EIT Emerging Implant Technologies GmbH
(K170503)
Reference Predicate
Devices	Crystal® - Spinal Elements, Inc. (K073351)
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.
Materials	ASTM F136 - Wrought Titanium-6Aluminum-4Vanadium ELI
ASTM F3001 - ASTM F3001 Additive Manufacturing Titanium-6 Aluminum-4 Vanadium
ELI
ASTM F2924 - ASTM F2924 Additive Manufacturing Titanium-6 Aluminum-4 Vanadium
Intended Use	BEE Cervical Cages were developed as an intercorporal implant for the anterior cervical
spondylodesis.
Substantial
Equivalence Claimed
to Predicate Devices	The BEE Cervical Cages are substantially equivalent to the predicate devices in terms
of intended use, design, materials used, mechanical safety and performances.
Indications for Use	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.
Summary of the
technological
characteristics
compared to
predicate	Intended Use
The BEE Cervical Cages and the predicate devices are all intended to be used to
maintain adequate disc space until fusion occurs.

Indications for Use
All of the devices comply with the indications for use specified in 21 CFR section
888.3080 for cervical interbody fusion devices |
| | Material
The BEE Cervical Cage uses the same material as the predicate device.

Design
The BEE Cervical Cage and the predicate are equivalent in terms of shape, material, and
manufacturing process. |
| | Sizes
The BEE Cervical Cage and the predicates are equivalent in their dimensions.

Strength
The BEE Cervical Cage has greater or equivalent strength values compared to other
devices cleared for use in the cervical spine. |
| Non-clinical Test
Summary | The following analyses were conducted:
• ASTM F2077 - Test Methods for Intervertebral Body Fusion Devices
• ASTM F2267 - Measuring Load Induced Subsidence of Intervertebral Body
Fusion Device Under Static Axial Compression

The results of these evaluations indicate that the BEE Cervical Cages are equivalent to
predicate devices. |
| Clinical Test
Summary | Clinical evidence was provided to demonstrate that the lattice structure did not obstruct the
development of fusion. |
| Conclusions: Non-
clinical and Clinical | NGMedical considers the BEE Cervical Cages to be equivalent to the predicate devices
listed above. This conclusion is based upon the devices' similarities in principles of
operation, technology, materials and indications for use. |

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

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