(285 days)
Not Found
No
The document describes a physical implantable device (intervertebral body fusion cage) and its associated instruments. There is no mention of software, algorithms, image processing, AI, ML, or any data processing that would suggest the use of AI/ML technology. The performance studies focus on the physical and biological properties of the device.
Yes
The device is an intervertebral body fusion device intended to facilitate interbody fusion for patients with Degenerative Disc Disease, which is a therapeutic purpose.
No
The device is an intervertebral body fusion device and not intended for diagnosis. Its purpose is to facilitate interbody fusion after surgical correction of spinal disorders.
No
The device description explicitly states that the NEO Cage System™ consists of physical cages made of titanium alloy and includes relevant instruments for implantation. This indicates it is a hardware medical device, not software-only.
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, 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 Neo Cage System™ is an implantable medical device designed to be surgically placed in the lumbosacral spine to facilitate bone fusion. It is a physical device used in vivo (within the body) during surgery.
- Lack of Diagnostic Testing: The description does not mention any testing of biological samples or any diagnostic function. Its purpose is structural support and promoting fusion, not analyzing biological markers.
Therefore, the Neo Cage System™ falls under the category of a surgical implant or a spinal fusion device, not an in vitro diagnostic device.
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 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.
Product codes
MAX
Device Description
The NEO Cage System™ is an intervertebral fusion device with autogenous 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 surqical technique. The cages of the Neo Cage system are made of titanium alloy according to ISO 5832-3 or ASTM F3001 and are supplied sterile. The system includes the relevant instruments which are single use only and delivered sterile. 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
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)
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). The results for endotoxin levels for all runs were
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Neo Medical S.A. Jonas Larsson CEO Route de Lausanne 157A Villette (Lavaux), Vaud, 1096, Switzerland
Re: K181048
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: December 28, 2018 Received: December 31, 2018
Dear Jonas Larsson:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Hwang -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Page 1 of 1
510(k) Number (if known) K181048
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 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 sketally mature and six months of non-operative treatment.
| 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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3
510(k) Summary
| Date prepared | December 10, 2018, according to 21 CFR 807.92 |
|---|---|
| --------------- | ----------------------------------------------- |
Purpose of submission
| 510(k) type | Traditional 510(k) |
|---|---|
| Purpose of submission | Introduction of a new cage system |
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 Stryker Tritanium Cage (K152304) as well as the following additional predicate devices: 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 autogenous 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 surqical technique. The cages of the Neo Cage system are made of titanium alloy according to ISO 5832-3 or ASTM F3001 and are supplied sterile. The system includes the relevant instruments which are single use only and delivered sterile. 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). The results for endotoxin levels for all runs were