(163 days)
Not Found
No
The summary describes a physical intervertebral body fusion device made of titanium alloy and its associated instruments. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on material properties, mechanical strength, sterilization, and biocompatibility, not computational performance.
Yes
The device is an intervertebral body fusion device intended to facilitate interbody fusion following surgical correction of spine disorders. It is used to treat Degenerative Disc Disease (DDD) at specific levels of the lumbosacral spine, which suggests a therapeutic purpose.
No
The NEO Cage System™ is an intervertebral body fusion device intended for stabilization and to promote bone fusion, not for diagnosing medical conditions.
No
The device description explicitly states the device is made of titanium alloy and includes instruments for implantation, indicating it is a physical medical device, not software only.
Based on the provided text, the NEO Cage System™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is an "intervertebral body fusion device intended to be used with autogenous bone graft to facilitate interbody fusion and to be used with supplemental spinal fixation systems". This describes a surgical implant used in vivo (within the body) to treat a structural issue (degenerative disc disease).
- Device Description: The description details a physical implant made of titanium alloy, along with instruments for implantation. This aligns with a surgical device, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The NEO Cage System™ is a surgical implant used to treat a condition directly within the patient's body.
N/A
Intended Use / Indications for Use
NEO Cage System™ is an intervertebral body fusion device intended to be used with autogenous bone graft to facilitate interbody fusion and to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage is to be implanted in open surgery via a posterior or transforaminal approach.
The indication for use is Degenerative Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have grade 1 Spondylolisthesis 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 six months of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The NEO Cage System™ is an intervertebral fusion device with bone graft intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The cages are intended to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage implants may be implanted via an open posterior approach.
The Neo Cage System™ consists of cages of different lengths, sizes and lordotic angles to adapt to a variety of patient anatomies. The size and form of the devices is adjusted to the morphology of the body and the surgical technique. The cages of the Neo Cage system are made of titanium alloy (Ti6Al4V) according to ISO 5832-3 or ASTM F3001 and are supplied sterile. The system includes the relevant instruments which are either single use only and delivered sterile or reusable. The Instruments are to be used for the implantation of the above mentioned medical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine, L2 to S1
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
orthopedic surgeons
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)
Sterilization validation: The minimal dose of 25kGy is validated using VDmax25 method as described in ISO 11137-2 and confirmed a Sterility Assurance Level SAL of 10-6.
Pyrogenicity: The pyrogenicity is tested with the LAL-Test (Limulustest).
Packaging validation: The sterile barrier system complies with ISO 11607-1. Real time and accelerated ageing studies as well as transport studies were performed to demonstrate 5-year shelf life and packaging integrity.
Biocompatibility: Biological evaluation has been performed in accordance with ISO 10993-1. Chemical Analysis according to ISO 10993-18 and Cytotoxicity testing according to ISO 10993-5 were performed on worst case components of the NEO Cage System™ for K181048. Cytotoxicity testing and testing of inorganic and organic residues was repeated to confirm biocompatibility of the line extension.
Mechanical testing: A new worst case cage is introduced with the line extension. Mechanical testing has therefore been repeated and completed successfully. The following tests were performed in accordance with ASTM F2077
- Static compression test ●
- Static shear compression test ●
- Static torsion test ●
- Dynamic compression test ●
- . Dynamic shear compression test
- . Dynamic torsion test
Additional testing included
- Subsidence test according to ASTM F2267
- Wear testing (debris) according to ISO 17853 ●
- Expulsion test ●
Trabecular structure: The trabecular structure has been characterized by tomography examination for the currently cleared cage NEO Cage System™ K181048 and is not affected by the line extension.
MRI Compatibility: The following tests were performed with the new worst-case regarding MRI related issues
- . Magnetic field interactions ASTM F2052-15
- MRI-related heating ASTM F2182-11a and .
- Artifacts ASTM F2119-07 (R2013) .
The NEO Cage System™ is MRI conditional and information is provided in the labeling.
Usability: Suitability of the instruments and use of the NEO Caqe System™ including its labeling was confirmed in a WetLab study with orthopedic surgeons.
Clinical Evaluation: Clinical studies were not required, based upon review an evaluation of scientific literature, comparison with similar devices and non-clinical performance data.
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.
NEO Cage System™ (K181048), Stryker Tritanium Cage (K152304), Spineart Juliet Ti (K153621), Medtronic Capstone (K073291), K082342, SpineVision SpaceVision System (K153783)
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
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December 13, 2019
Neo Medical S.A. % Mr. Charles Cathlin President Confinis Corporation 15807 Glacier Ct North Potomac, Maryland 20878
Re: K191796
Trade/Device Name: NEO Cage System™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 4, 2019 Received: November 12, 2019
Dear Mr. Cathlin:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 L. Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191796
Device Name NEO Cage System™
Indications for Use (Describe)
NEO Cage System™ is an intervertebral body fusion device intended to be used with autogenous bone graft to facilitate interbody fusion and to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage is to be implanted in open surgery via a posterior or transforaminal approach.
The indication for use is Degenerative Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have grade 1 Spondylolisthesis 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 six months of non-operative treatment.
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
| Date prepared | October 28, 2019, according to 21 CFR 807.92 |
|---|---|
| --------------- | ---------------------------------------------- |
Purpose of submission
| 510(k) type | Traditional 510(k) |
|---|---|
| Purpose of submission | Line extension to currently cleared NEO Cage |
| SystemTM K181048 |
Submitter information
| Submitter | Neo Medical S.A.
Route de Lausanne 157 A
1096 Villette (Lavaux), Switzerland |
|------------------------------------------|---------------------------------------------------------------------------------------|
| Contact US agent
confinis corporation | Mr. Charles Cathlin
Mailto: charles.cathlin@confinis.com
Phone: +1 240 252 0891 |
Device name and classification
| Trade name | NEO Cage System™ |
|---|---|
| Common name | Intervertebral body fusion device |
| Device panel | Orthopedic |
| Classification name | Intervertebral body fusion device |
| Class | II |
| Product code | MAX |
| CFR section | 888.3080 |
Predicate devices
The NEO Cage System™ is substantially equivalent to the primary predicate device NEO Cage System™ (K181048) as well as the following additional predicate devices: Stryker Tritanium Cage (K152304), Spineart Juliet Ti (K153621), Medtronic Capstone (K073291 (initial), K082342 (PEEK introduced)) and SpineVision SpaceVision System (K153783).
4
Indications for use
Neo Cage System™ is an intervertebral body fusion device intended to be used with autogenous bone graft to facilitate interbody fusion and to be used with supplemental spinal fixation systems that have been cleared for the lumbosacral spine. The cage is to be implanted in open surgery via a posterior or transforaminal approach.
The indication for use is Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have grade 1 Spondylolisthesis 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.
Device description
The NEO Cage System™ is an intervertebral fusion device with bone graft intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The cages are intended to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage implants may be implanted via an open posterior approach.
The Neo Cage System™ consists of cages of different lengths, sizes and lordotic angles to adapt to a variety of patient anatomies. The size and form of the devices is adjusted to the morphology of the body and the surgical technique. The cages of the Neo Cage system are made of titanium alloy (Ti6Al4V) according to ISO 5832-3 or ASTM F3001 and are supplied sterile. The system includes the relevant instruments which are either single use only and delivered sterile or reusable. The Instruments are to be used for the implantation of the above mentioned medical devices.
Summary of testing
Sterilization validation: The minimal dose of 25kGy is validated using VDmax25 method as described in ISO 11137-2 and confirmed a Sterility Assurance Level SAL of 10-6.
Pyrogenicity: The pyrogenicity is tested with the LAL-Test (Limulustest).
Packaging validation: The sterile barrier system complies with ISO 11607-1. Real time and accelerated ageing studies as well as transport studies were performed to demonstrate 5-year shelf life and packaging integrity.
Biocompatibility: Biological evaluation has been performed in accordance with ISO 10993-1. Chemical Analysis according to ISO 10993-18 and Cytotoxicity testing according to ISO 10993-5 were performed on worst case components of the NEO Cage System™ for K181048. Cytotoxicity testing and testing of inorganic and organic residues was repeated to confirm biocompatibility of the line extension.
5
Mechanical testing: A new worst case cage is introduced with the line extension. Mechanical testing has therefore been repeated and completed successfully. The following tests were performed in accordance with ASTM F2077
- Static compression test ●
- Static shear compression test ●
- Static torsion test ●
- Dynamic compression test ●
- . Dynamic shear compression test
- . Dynamic torsion test
Additional testing included
- Subsidence test according to ASTM F2267
- Wear testing (debris) according to ISO 17853 ●
- Expulsion test ●
Trabecular structure: The trabecular structure has been characterized by tomography examination for the currently cleared cage NEO Cage System™ K181048 and is not affected by the line extension.
MRI Compatibility: The following tests were performed with the new worst-case regarding MRI related issues
- . Magnetic field interactions ASTM F2052-15
- MRI-related heating ASTM F2182-11a and .
- Artifacts ASTM F2119-07 (R2013) .
The NEO Cage System™ is MRI conditional and information is provided in the labeling.
Usability: Suitability of the instruments and use of the NEO Caqe System™ including its labeling was confirmed in a WetLab study with orthopedic surgeons.
Clinical Evaluation: Clinical studies were not required, based upon review an evaluation of scientific literature, comparison with similar devices and non-clinical performance data.
Conclusion
The NEO Cage System™ is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function.
Non-clinical performance testing demonstrates that the NEO Cage System™ meets the requirements according to FDA Guidance for Intervertebral Body Fusion Device, issued on June 12, 2007, and is as safe and effective as its predicate devices.