(141 days)
No
The summary describes a physical implant (cage) for spinal fusion and its mechanical properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is indicated for use in cervical intervertebral body fusion procedures for patients with degenerative disc disease, which aims to treat or alleviate a medical condition.
No
This device is an implantable medical device used in spinal fusion procedures, specifically a cervical intervertebral body fusion cage, and is not designed for diagnostic purposes.
No
The device description clearly states it is a physical implant made of PEEK material with tantalum markers, designed to be surgically implanted. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant used in cervical intervertebral body fusion procedures. It is a physical device implanted into the body to restore disc height and facilitate fusion.
- Device Description: The description details a physical implant made of PEEK material with specific structural features for surgical implantation.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on biological samples.
- Performance Studies: The performance studies described are mechanical tests on the physical implant, not studies related to the accuracy or performance of a diagnostic test.
Therefore, the 4CIS® Marlin PEEK ACIF Cage is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
4CIS® Marlin PEEK ACIF Cage is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy in advance. The 4CIS® Marlin PEEK ACIF Cage is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach. It is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine, such as Anterior Cervical Plate system.
Product codes
ODP
Device Description
4CIS® Marlin PEEK ACIF Cage is single component devices used to restore height of disc space by anterior approach and to facilitate cervical interbody fusion with maintaining physiological lordotic angulation of cervical spine. To allow maximum preservation and ensure ample contact surfaces with bony endplate, a variety of shapes and sizes are available and each device has three tantalum markers for ease of visualization on radiographs. The 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 bone graft material to be filled. The implant has safety proven structure and material (Poly-ether-ether-ketone, ASTM F2026) 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
Not Found
Anatomical Site
cervical intervertebral body, C2-C3 disc to the C7-T1 disc, cervical spine
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)
Mechanical testing (static axial compression, static compression-shear, static torsion, dynamic axial compression, dynamic compression-shear, dynamic torsion and static subsidence) was conducted in accordance with ASTM F2077-17 and F2267-04.
Above non-clinical performance data in the form of a comprehensive literature review was provided in support of substantial equivalence of the subject device.
Conclusion: The overall technology characteristics and mechanical performance data lead to the conclusion that the subject device is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
4CIS® Marlin ACIF Cage System (K162402), PATRIOT SPACERS: COLONIAL ACDF (K072991), TRYPTIK Ca (K091873), MATISSE Anterior Cervical Interbody Fusion Cage System (K162682)
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.
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 & Human Services logo. To the right of that 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.
December 19, 2019
Solco Biomedical Co., Ltd. Hwi-Geun Yu RA & Exam Certification Team Leader 154 Seotan-ro, Seotan-myeon Pyeongtaek-Si, Gyeonggi-do, 17704 Republic of Korea
Re: K192044
Trade/Device Name: 4CIS Marlin PEEK ACIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: November 29, 2019 Received: December 4, 2019
Dear Hwi-Geun Yu:
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 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 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
K192044
Device Name
4CIS® Marlin PEEK ACIF Cage
Indications for Use (Describe)
4CIS® Marlin PEEK ACIF Cage is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy in advance. The 4CIS® Marlin PEEK ACIF Cage is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach. It is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine, such as Anterior Cervical Plate system.
| 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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3
510(k) Summary
| Submitter | Solco Biomedical Co., Ltd.
154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do,
17704 Republic of Korea
Phone. +82-31-664-4101
Fax. +82-31-663-8983 |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Hwi-geun Yu
Solco Biomedical Co., Ltd.
154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do,
17704 Republic of Korea
Phone: +82-31-610-4091
Fax: +82-31-663-8983 |
| Preparation Date | July 22, 2019 |
| Trade / Proprietary name | 4CIS® Marlin PEEK ACIF Cage |
| Common / Usual Name | Cervical Intervertebral Body Fusion Device |
| Classification Name
Classification Code
Regulatory Class
Regulation Number | Intervertebral Fusion Device With Bone Graft, Cervical
ODP
Class II
888.3080 |
| Predicate Device | 4CIS® Marlin ACIF Cage System (K162402) [Solco
Biomedical Co., Ltd.] - Primary Predicate
PATRIOT SPACERS: COLONIAL ACDF (K072991,
Additional)
TRYPTIK Ca (K091873, Additional)
MATISSE Anterior Cervical Interbody Fusion Cage
System (K162682, Additional) |
| Description of Device | 4CIS® Marlin PEEK ACIF Cage is single component
devices used to restore height of disc space by anterior
approach and to facilitate cervical interbody fusion with
maintaining physiological lordotic angulation of cervical
spine. To allow maximum preservation and ensure ample
contact surfaces with bony endplate, a variety of shapes and
sizes are available and each device has three tantalum
markers for ease of visualization on radiographs. The
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 bone graft material to be
filled. The implant has safety proven structure and material
(Poly-ether-ether-ketone, ASTM F2026) to promote
biological synostosis and assures mechanical safety against
load. |
| Indication for Use | 4CIS® Marlin PEEK ACIF Cage is indicated for use in
cervical intervertebral body fusion procedures in skeletally
mature patients with degenerative disc disease (DDD) at the
levels from the C2-C3 disc to the C7-T1 disc. DDD is defined
as neck pain of discogenic origin with degeneration of the disc
confirmed by patient history and radiographic studies. These
patients should have six weeks of non-operative therapy in
advance. The 4CIS® Marlin PEEK ACIF Cage is to be used
with autogenous bone graft and/or allogenic bone graft
comprised of cancellous and/or corticocancellous bone graft,
and is to be implanted via an open, anterior approach. It is
intended to be used with supplemental spinal fixation systems
that have been cleared for use in the cervical spine, such as
Anterior Cervical Plate system. |
| 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 Data | Mechanical testing (static axial compression, static
compression-shear, static torsion, dynamic axial compression,
dynamic compression-shear, dynamic torsion and static
subsidence) was conducted in accordance with ASTM F2077-
17 and F2267-04.
Above non-clinical performance data in the form of a
comprehensive literature review was provided in support of
substantial equivalence of the subject device. |
| Conclusion | The overall technology characteristics and mechanical
performance data lead to the conclusion that the subject device
is substantially equivalent to legally marketed predicate
devices. |
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K192044
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