(395 days)
No
The device description and intended use focus on the physical characteristics and function of a spinal fusion cage. There is no mention of AI, ML, or any software-driven analysis or processing of data. The performance studies are mechanical tests, not related to algorithmic performance.
Yes.
The device is intended to treat Degenerative Disk Disease and facilitate spinal fusion, which are therapeutic interventions.
No
Explanation: The device is an intervertebral body fusion cage intended for surgical implantation to treat degenerative disk disease, not for diagnosing it. It is a therapeutic device.
No
The device description clearly states it is an implantable intervertebral body fusion device made of PEEK Polymer and Titanium, which are hardware components.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Spinal Fusion Cage System is an implantable device used to facilitate fusion in the lumbar spine. It is a physical device inserted into the body during surgery.
- Intended Use: The intended use is to treat Degenerative Disk Disease by providing structural support and promoting bone fusion. This is a therapeutic intervention, not a diagnostic test.
- No Mention of Samples or Testing: The description does not mention any analysis of biological samples or diagnostic testing.
Therefore, the Spinal Fusion Cage System falls under the category of a medical device (specifically, an implantable surgical device), but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Spinal Fusion Cage System is an intervertebral body fusion devices intended for use to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Spinal Fusion Cage System is indicated to be used with autologous bone graft to facilitate fusion and are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of nonoperative treatment.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Spinal Fusion Cage System is a device intended for use as an intervertebral body fusion device in the lumbosacral region (L2-S1) of the spine. It is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation. The Spinal Fusion Cage System is single component devices used to restore height of disc and to facilitate lumbar intervertebral body fusion with maintaining physiological lordotic angulation of lumbar spine. To allow maximum preservation and ensure ample contact surfaces with bony endplate, a variety of shapes and sizes are available and each device made with PEEK Polymer has tantalum (ASTM F560) markers for ease of visualization on radiographs. Vertical square teeth on the top and the bottom surface prevent subsidence of the cage into the vertebral body while they increase the anchoring and prevent slipping or expulsion. To make solid fusion of intervertebral body, hollow space in the implant allows autologous bone graft material to be filled. The implant has safety proven structure and material (Polyetheretherketone, ASTM F2026 & Titanium Ti6Al4V Eli ASTM F136) to promote biological synostosis and assures mechanical safety against load.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographs
Anatomical Site
Lumbar spine, L2-S1
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)
Non-clinical testing was performed to demonstrate that the subject device is equivalent to the predicate device. The following testing was performed in accordance with the ASTM F2077-14 and F2267-04:
- Static Axial Compression
- Dynamic Axial Compression
- Subsidence
The subject device demonstrated equivalent mechanical performance to the cited predicate device under the same test conditions.
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.
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December 19, 2022
SOLCO Biomedical Company India Private Limited Darshak Shah Director 5 & 6 Third Floor, B Jadav Chambers, Above Sales India Ahmedabad, Gujarat 380009 India
Re: K213653
Trade/Device Name: 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 7, 2022 Received: December 12, 2022
Dear Darshak Shah:
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.
1
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 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.
Katherine D. Kavlock -S
for 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) K213653
Device Name 4CIS BLACK MARLIN PLIF CAGE SYTEM 4CIS DOLPHIN TLIF CAGE SYSTEM
Indications for Use (Describe)
The Spinal Fusion Cage System is an intervertebral body fusion devices intended for use to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Spinal Fusion Cage System is indicated to be used with autologous bone graft to facilitate fusion and are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of nonoperative treatment.
| 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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Image /page/3/Picture/0 description: The image shows the word "SOLCO" in large, bold, dark blue letters. The letters are sans-serif and appear to be a custom font. To the right of the word, there is a small red circle, which is likely part of the logo. The background is plain white.
"510(K) SUMMARY"
This summary of 510(k) substantial equivalence information isbeing submitted in accordacne with requirement of 21 CFR 807.92.
| Submitter | SOLCO Biomedical Company India Private Limited
Survey No.1540, Beside Torrent Pharma, Village-Rajpur
Ahmedabad Mehsana Highway, Ta-Kadi, Dist-Mehsana
Gujarat- 382715, INDIA. | | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Contact Person | Darshak Shah
Director
SOLCO Biomedical Company India Private Limited
Phone : +91 98252 06091, Email: darshak@solco.co.in | | |
| Submission Date | Thursday, December 15, 2022 | | |
| Trade / Proprietary name | 4CIS BLACK MARLIN PLIF CAGE SYSTEM
4CIS DOLPHIN TLIF CAGE SYSTEM | | |
| Classification Name | Intervertebral body Fusion Device | | |
| Classification Code | MAX | | |
| Regulatory Class | Class II | | |
| Regulation Number | 21 CFR 888.3080 | | |
| | 510K
Number | Trade or Proprietary or Model Name | Manufacturer |
| Predicate Device | K221844
(Primary) | TDM Lumbar Interbody Fusion Cage
System | TDM Co. Ltd. Korea |
| | K190563 | 4CIS® PEEK PLIF Cage,
4CIS® Pebble Beach PEEK PLIF Cage
4CIS® Torrey Pines PEEK TLIF Cage | Solco Biomedical Co., Ltd.
Republic of Korea |
| | K202498
(Reference) | 4CIS SARA Spine System
4CIS VERTU Spine System | Solco Biomedical Company
India Private limited |
| | K162358 | T-PAL Spacer System,
T-PAL Titanium Spacer System,
SYNFIXEvolution System | Synthes USA Products LLC |
4
| | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED | K213653
PAGE NO 2 of 3 |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| | device intended for use as an intervertebral body fusion device in the lumbosacral region
(L2-S1) of the spine. It is implanted using a posterior or transforaminal approach and is
intended to be used singly or in pairs with supplemental fixation.
The Spinal Fusion Cage System is single component devices used to restore height of
disc and to facilitate lumbar intervertebral body fusion with maintaining physiological
lordotic angulation of lumbar spine. To allow maximum preservation and ensure ample
contact surfaces with bony endplate, a variety of shapes and sizes are available and each
device made withh PEEK Polymer has tantalum (ASTM F560) markers for ease of
visualization on radiographs. Vertical square teeth on the top and the bottom surface
prevent subsidence of the cage into the vertebral body while they increase the anchoring
and prevent slipping or expulsion. To make solid fusion of intervertebral body, hollow
space in the implant allows autologous bone graft material to be filled. The implant has
safety proven structure and material (Polyetheretherketone, ASTM F2026 & Titanium
Ti6Al4V Eli ASTM F136) to promote biological synostosis and assures mechanical safety
against load. | |
| Indication for Use | The Spinal Fusion Cage System is an intervertebral body fusion devices intended for use
to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine
with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is
defined as discogenic back pain with degeneration of the disc confirmed by history and
radiographic studies. Spinal Fusion Cage System is indicated to be used with autologous
bone graft to facilitate fusion and are intended to be used with supplemental fixation. The
device is to be used in patients who have had six months of non-operative treatment. | |
| Comparison of
Technological
Characteristics
with the
Predicate Devices | The subject device and all the predicates have the same or similar indications for use
statements. The subject device is composed of the same material as the predicate
devices conforming to recognized industry standards for permanent implants and surgical
orthopedic instruments. All they have similar basic design features and functions as well
as those dimensions. The subject device and cited predicate devices are provided non-
sterile for single use only. The subject device demonstrated equivalent mechanical
performance to the cited predicate device under the same test conditions. | |
| Performance Testing | Non-clinical testing was performed to demonstrate that the subject device is equivalent to
the predicate device. The following testing was performed in accordance with the ASTM | |
| | F2077-14 and F2267-04:
- Static Axial Compression
- Dynamic Axial Compression
- Subsidence | |
| Conclusion | The overall technology characteristics, material of construction, mechanical performance and design characteristics lead to the conclusion that subject device is substantially equivalent to legally marketed predicate devices for intended use,material composition, principles of operation, and design. | |
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