(113 days)
Not Found
No
The summary describes a passive implantable device (a PLIF cage) used for spinal fusion. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The device description focuses on its material, manufacturing process, and physical characteristics.
Yes.
The device is an implantable cage used for anterior lumbar interbody fusion to treat degenerative disc disease, which falls under the definition of a therapeutic device as it is intended to mitigate or treat a disease or condition.
No
The device is an interbody fusion cage used for treatment, not for diagnosing conditions. Its function is to facilitate fusion, not to identify or assess a disease.
No
The device description clearly states it is a lumbar interbody fusion device manufactured from titanium alloy, which is a physical hardware component.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a lumbar interbody fusion device) used to facilitate bone fusion in the spine. It is physically implanted into the patient's body.
- Lack of Diagnostic Activity: There is no mention of this device analyzing biological samples or providing diagnostic information. Its function is purely mechanical and biological (facilitating fusion).
Therefore, based on the provided information, the BEE® PLIF cage is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BEE® PLIF cages are indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplementation, which has been cleared by the FDA for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The subject BEE® PLIF Cage is a lumbar interbody fusion device. BEE® PLIF Cage is manufactured from titanium alloy per ASTM F3001 via additive manufacturing. The BEE® PLIF Cage is an intervertebral body fusion device for treatment of lumbar disc degeneration utilizing the posterior lateral approach. BEE®PLF Cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The cranial and caudal side of the implant is rough to provide increased stability and to help prevent movement of the device. It is not allowed to use BEE® PLIF implants in contact with components of other manufacturers with the exception of autograft materials. BEE® PLIF Cage is intended for single use only and is provided sterile, using gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine)
Indicated Patient Age Range
skeletally mature
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)
The following mechanical testing was performed according to ASTM F2077: Static and dynamic axial compression, Static and dynamic compression shear, and Static and dynamic torsion. Subsidence was performed in accordance with ASTM F2276, in addition to performance of expulsion testing. All tests confirmed that the product met the predetermined acceptance criteria. In particular, non-clinical bench performance testing demonstrated that the BEE®PLIF Cage is substantially equivalent to previously cleared 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.
K100945, K170503, K201605, K200429
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.
Not Found
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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 27, 2021
NGMedical GmbH % Christine Scifert Partner MRC Global, LLC 9085 East Mineral Circle, Suite 110 Centennial. Colorado 80112
Re: K211413
Trade/Device Name: BEE® PLIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 4, 2021 Received: August 5, 2021
Dear Ms. 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 L. 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) K211413
Device Name BEE® PLIF Cage
Indications for Use (Describe)
BEE® PLIF cages are indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplementation, which has been cleared by the FDA for use in the lumbar spine.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| -- | ------------------------------------------------- | -- |
X 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® PLIF Cage 27 June 2021
| Company: | NGMedical GmbH
Talsperrenblick 5
66620 Nonnweiler
GERMANY
+49 6873 99997-100 |
|-------------------------|-------------------------------------------------------------------------------------------|
| Company Contact: | Stella Hahn – Head of Regulatory Affairs
+49 6873 99997-100 |
| Official Correspondent: | Christine Scifert – MRC Global, LLC
Christine.scifert@askmrcglobal.com
901-831-8053 |
| Trade Name: | BEE® PLIF Cage |
| Common Name: | Intervertebral Fusion Device With Bone Graft, Lumba |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3080 (Intervertebral body fusion device) |
| Panel: | Orthopedic |
| Product Code: | MAX |
Device Description:
The subject BEE® PLIF Cage is a lumbar interbody fusion device. BEE® PLIF Cage is manufactured from titanium alloy per ASTM F3001 via additive manufacturing. The BEE® PLIF Cage is an intervertebral body fusion device for treatment of lumbar disc degeneration utilizing the posterior lateral approach. BEE®PLF Cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The cranial and caudal side of the implant is rough to provide increased stability and to help prevent movement of the device. It is not allowed to use BEE® PLIF implants in contact with components of other manufacturers with the exception of autograft materials. BEE® PLIF Cage is intended for single use only and is provided sterile, using gamma irradiation.
Indications for Use:
BEE® PLIF cages are indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants
4
may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Substantial Equivalence:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate: Advanced Medical Technologies - FUSE Cages - K100945 Secondary Predicates: EIT Emerging Implant Technologies GmbH - EIT Cellular Titanium® PLIF Cages - K170503, K201605 NG Medical, Ngmh GmbH - BEE®Cage - K200429
The subject and predicate devices are similar in Intended Use, Technological Characteristics, Performance Specifications, and Material. Therefore, it can be concluded that the subject BEE® PLIF Cage does not raise new questions of safety and effectiveness when compared to the predicate devices.
Performance Testing:
In accordance with the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", a biocompatibility evaluation was performed.
The following mechanical testing was performed according to ASTM F2077: Static and dynamic axial compression, Static and dynamic compression shear, and Static and dynamic torsion. Subsidence was performed in accordance with ASTM F2276, in addition to performance of expulsion testing. All tests confirmed that the product met the predetermined acceptance criteria. In particular, non-clinical bench performance testing demonstrated that the BEE®PLIF Cage is substantially equivalent to previously cleared devices.
Conclusion:
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.