(60 days)
No
The summary describes a physical implant 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 cage implanted in the cervical spine to treat Degenerative Disc Disease, which is a medical condition. This directly impacts the structure and function of the body for therapeutic purposes.
No
This device is an interbody fusion cage intended for the treatment of Degenerative Disc Disease in the cervical spine. Its purpose is to provide stability and promote fusion, not to diagnose a condition.
No
The device description clearly states it consists of physical implants (cages, screws, and plates) made from titanium, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a surgical implant designed to be placed within the human body (in the cervical spine) to treat Degenerative Disc Disease. It is a physical device used for structural support and fusion, not for analyzing biological samples.
The information provided focuses on the mechanical properties, materials, and surgical application of the device, which are characteristic of a medical device intended for implantation, not an IVD.
N/A
Intended Use / Indications for Use
The Hive™ Standalone Cervical System with NanoHive® Surface Technology is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 weeks of non-operative treatment pror to treatment with the device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous or corticocancellous bone. These devices are intended to be used with the screws which accompany the implants. When used with the accompanying screws, these devices may be used as standalone interbody devices. If the accompanying screws are not used, the device is intended for use with supplemental fixation. When used as a standalone system, the Hive™ Standalone Cervical System is intended for use at one or two levels (C2-T1) and must be used with the provided bone screws.
Product codes (comma separated list FDA assigned to the subject device)
OVE, ODP
Device Description
The Hive™ Standalone Cervical System consists of additively manufactured interbody fusion cages made from Ti-6Al-4V per ASTM F3001 and screws and plates made from Ti-6Al-4V per ASTM F136. The titanium cages take the form of a highly porous core which is surrounded at the cephalad and caudal ends by protective solid titanium endplates. The implant is anatomic in shape and has teeth to ensure placement is maintained after implantation. Implants incorporate features for fixating the device to the vertebral body in a stand-alone manner using either interfixated features within the intervertebral space or outer plate fixation on the anterior surface of the vertebral bodies. Inter-fixation and outer-fixation allow adjustable placement of fixation components.
The implant components of the Hive™ Standalone Cervical System are offered in a variety of sizes to accommodate patient anatomy and surgical approach. The implants are also offered in various lordotic configurations to ensure proper stability and alignment of the spine for differing patient anatomy. The implants are provided pre-sterile, in validated sterile packaging, and are single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2-T1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
The Hive™ Standalone Cervical System has been tested in the following test modes:
- . Static and Dynamic Axial Compression per ASTM F2077
- Static and Dynamic Compression Shear per ASTM F2077
- Static and Dynamic Torsion per ASTM 2077
- Subsidence per ASTM F2267 .
- . Expulsion
The results of this non-clinical testing show that the strength of the Hive™ Standalone Cervical System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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.
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.
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 12, 2022
NanoHive Medical LLC % Nathan Wright, MS Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K223190
Trade/Device Name: Hive™ Standalone Cervical System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: October 12, 2022 Received: October 13, 2022
Dear Nathan Wright:
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 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 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
Enclosure
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Indications for Use
510(k) Number (if known) K223190
Device Name Hive™ Standalone Cervical System
Indications for Use (Describe)
The Hive™ Standalone Cervical System with NanoHive® Surface Technology is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 weeks of non-operative treatment pror to treatment with the device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous or corticocancellous bone. These devices are intended to be used with the screws which accompany the implants. When used with the accompanying screws, these devices may be used as standalone interbody devices. If the accompanying screws are not used, the device is intended for use with supplemental fixation. When used as a standalone system, the Hive™ Standalone Cervical System is intended for use at one or two levels (C2-T1) and must be used with the provided bone screws.
| 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
| Submitter's Name: | NanoHive Medical LLC |
|---|---|
| Submitter's Address: | 12 Gill Street, Suite 4500 |
| Woburn, Massachusetts 01801 | |
| Submitter's Telephone: | 844-943-5433 |
| Contact Person: | Nathan Wright MS |
| Empirical Technologies | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | October 12, 2022 |
| Trade or Proprietary Name: | Hive™ Standalone Cervical System |
| Classification Name: | Intervertebral Fusion Device with Integrated Fixation, Cervical |
| Intervertebral Fusion Device with Bone Graft, Cervical | |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE, ODP |
| Classification Panel: | Orthopedic Devices – Spinal Devices (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Hive™ Standalone Cervical System consists of additively manufactured interbody fusion cages made from Ti-6Al-4V per ASTM F3001 and screws and plates made from Ti-6Al-4V per ASTM F136. The titanium cages take the form of a highly porous core which is surrounded at the cephalad and caudal ends by protective solid titanium endplates. The implant is anatomic in shape and has teeth to ensure placement is maintained after implantation. Implants incorporate features for fixating the device to the vertebral body in a stand-alone manner using either interfixated features within the intervertebral space or outer plate fixation on the anterior surface of the vertebral bodies. Inter-fixation and outer-fixation allow adjustable placement of fixation components.
The implant components of the Hive™ Standalone Cervical System are offered in a variety of sizes to accommodate patient anatomy and surgical approach. The implants are also offered in various lordotic configurations to ensure proper stability and alignment of the spine for differing patient anatomy. The implants are provided pre-sterile, in validated sterile packaging, and are single-use only.
INDICATIONS FOR USE
The Hive™ Standalone Cervical System with NanoHive® Surface Technology is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device is indicated to be used with autograft bone and/or
4
allograft bone comprised of cancellous or corticocancellous bone. These devices are intended to be used with the screws which accompany the implants. When used with the accompanying screws, these devices may be used as standalone interbody devices. If the accompanying screws are not used the device is intended for use with supplemental fixation.
When used as a standalone system, the Hive™ Standalone Cervical System is intended for use at one or two levels (C2-T1) and must be used with the provided bone screw.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- . Indications for Use
- Principle of Operation ●
- Structural Support Mechanism ●
- Materials ●
- . Sterility
- . Sizes
- Manufacturing and Biocompatibility ●
| 510k
Number | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate
Type |
|----------------|-------------------------------------------------------|-------------------------------------|---------------|-------------------|
| K212904 | SeaSpine WaveForm™ C Interbody System | SeaSpine Orthopedics
Corporation | OVE, ODP | Primary |
| K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | OVE | Additional |
| K190885 | Elevation Spine Saber-C System | Elevation Spine | OVE, ODP, KWQ | Additional |
| K200541 | Hive™ Stand-alone Anterior Lumbar
Interbody System | HD LifeSciences | OVD, MAX | Reference |
Performance Data
The Hive™ Standalone Cervical System has been tested in the following test modes:
- . Static and Dynamic Axial Compression per ASTM F2077
- Static and Dynamic Compression Shear per ASTM F2077 ●
- Static and Dynamic Torsion per ASTM 2077 ●
- Subsidence per ASTM F2267 .
- . Expulsion
The results of this non-clinical testing show that the strength of the Hive™ Standalone Cervical System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
5
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Hive™ Standalone Cervical System is substantially equivalent to the predicate device.