(627 days)
Not Found
No
The summary describes a physical implant device for spinal fusion and does not mention any software or analytical components that would utilize AI/ML.
Yes
The device is an intervertebral body fusion device indicated for treating Degenerative Disc Disease, which is a medical condition. Its purpose is to provide structural support for bone growth and fusion in the spine, which aligns with the definition of a therapeutic device.
No
Explanation: The device is an intervertebral body fusion cage, which is a therapeutic device implanted during surgery to promote bone fusion. It does not perform any diagnostic functions like identifying or analyzing medical conditions.
No
The device description clearly states it is a physical intervertebral body fusion cage constructed from titanium alloy.
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.
- Device Function: The 3d Cage is an implantable medical device designed to provide structural support and facilitate bone fusion in the spine. It is surgically placed within the body.
- Intended Use: The intended use clearly describes a surgical procedure for treating Degenerative Disc Disease by fusing vertebrae. This is a therapeutic intervention, not a diagnostic test.
- Device Description: The description details the material, manufacturing method, and physical structure of the implant. It does not mention any components or processes related to analyzing biological samples.
The information provided describes a medical device used in a surgical procedure, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The 3d Cage is an intervertebral body fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. The device is indicated to be used with a supplemental fixation system and autograft bone.
Product codes
MAX
Device Description
3d Cage™ is an intervertebral body fusion cage intended for use in (Posterior/Transforaminal) lumbar spinal fixation procedures. It is an open architecture truss designed to provide effective structural support with open space throughout the implant for bone growth and fusion. The cage is provided sterile and constructed from titanium alloy (Ti-6Al-4V, ASTM F3001) using Selective Laser Melting (SLM) method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-L5
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)
The worst-case device was tested in static and dynamic compression, static and dynamic compression shear (ASTM F2077) and subsidence (ASTM F2267).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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October 28, 2019
FIMS Co., Ltd. Younggwang Choi RA Team Staff B1, 440, Ghangnyong-daero, Yeongtong-gu Suwon-si, Gyeonggi-do 16229 Korea
Re: K180347
Trade/Device Name: 3d Cage™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 18, 2019 Received: October 23, 2019
Dear Younggwang Choi:
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
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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,
for Ronald P. Jean, PhD 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
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Indications for Use
510(k) Number (if known) K180347
Device Name 3d Cage™
Indications for Use (Describe)
The 3d Cage is an intervertebral body fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. The device is indicated to be used with a supplemental fixation system and autograft bone.
| 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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FIMS
510(k) Summary
10/24/2019
1. Company
| Submitter | |
|---|---|
| Name | FIMS Co., Ltd. |
| Address | B1, 440, Changnyong-daero, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea |
| Rep. | |
| Phone/Fax | +82-70-7098-6352/ +82-31-261-8649 |
| Contact person | Younggwang Choi / RA |
| ygchoi@genoss.com | |
| Summary Date | 10/24/2019 |
2. Device Name
| Proprietary name: | 3d CageTM |
|---|---|
| Regulation number: | 21 CFR 888.3080 |
| Classification name: | Intervertebral fusion device with Bone Graft, Lumbar |
| Product code: | MAX |
| Device class: | Class II |
3. Predicated Device
-
- Primary Predicated device
| K170503 | EIT Cellular Titanium ® PLIF CAGE, TLIF CAGE |
|---|---|
| 2) Additional Predicated device | |
| K111820 | SYNSTER® (CERVICAL, ALIF, PLF, PTLIF and TLIF)Cage |
| K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion Device |
510(k) Summary
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FIMS
4. Description
3d Cage™ is an intervertebral body fusion cage intended for use in (Posterior/Transforaminal) lumbar spinal fixation procedures. It is an open architecture truss designed to provide effective structural support with open space throughout the implant for bone growth and fusion. The cage is provided sterile and constructed from titanium alloy (Ti-6Al-4V, ASTM F3001) using Selective Laser Melting (SLM) method.
5. Indication for use
The 3d Cage is an intervertebral body fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy. The device is indicated to be used with a supplemental fixation system and autograft bone.
6. Technological Characteristics
The purpose of this premarket notification is to obtain clearance to market the 3d Cage™ is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options.
The 3d Cage™ Implant components are made of titanium 6-aluminum 4-vanadium alloy that conforms to ASTM F3001.
The subject system has similar technological characteristics as the predicate devices identified above.
Substantially equivalent result of non-clinical testing relative static and dynamic testing (per ASTM F2077-18, 14), subsidence testing (per ASTM F2267-04).
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FIMS
7. Performance Data
The worst-case device was tested in static and dynamic compression, static and dynamic compression shear (ASTM F2077) and subsidence (ASTM F2267).
Review
FIMS 3d Cage™ have the similar technological characteristics as the predicate device; including the material, indication for use, and design.
8. Conclusion
Based on the information provided in this premarket notification of FIMS Co., Ltd. concludes that FIMS 3d Cage™ are substantially equivalent to predicate devices.