(174 days)
No
The device description and performance studies focus on the mechanical properties and design of a physical implant (cage) for spinal fusion, with no mention of software, algorithms, or data processing that would indicate 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 a medical condition.
No
This device is an implantable cage system used for cervical intervertebral body fusion. Its purpose is to facilitate fusion, not to diagnose a medical condition. While it mentions "radiographic studies" for confirming degenerative disc disease, the device itself is not performing the diagnostic function; it is a treatment device. The x-ray markers are for visualization, not diagnosis.
No
The device description clearly states the device is a physical implantable cage made of PEEK or Titanium alloy, with x-ray markers. It 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 is for cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease. This is a surgical implant used to provide structural support and facilitate bone fusion.
- Device Description: The device is a physical cage made of PEEK or Titanium alloy, designed to be implanted into the spine. It is filled with bone graft material.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples (blood, urine, tissue, etc.) to diagnose a condition, monitor a treatment, or screen for diseases. Its function is purely structural and therapeutic.
- Input Imaging Modality: While radiographs are mentioned, they are used to visualize the placement and fusion process of the implant, not as input for a diagnostic algorithm performed by the device itself.
In summary, the 4CIS® Marlin ACIF Cage System is a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
4CIS® Marlin ACIF Cage System is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from 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. The 4CIS® Marlin ACIF Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous 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 ACIF cages are hollow, generally rectangular box shape made either from poly-ether-ether-ketone [PEEK-OPTIMA® LT1 (Invibio, Inc., West Conshohocken, PA USA) / VESTAKEEP® i4R (Evonik Industries, Essen Germany)] or Titanium alloy according to ASTM F2026(PEEK), F136(64ELI), F560(Tantalum). The cages are available in a variety of sizes and geometric options to fit the anatomical needs of a wide variety of patients. The device is filled with a bone graft material and inserted into the intervertebral body space of the cervical spine through an anterior cervical approach. As the design requirements, this cage design maintains the spacing between two vertebral bones following discectomy until fusion occurs. Each PEEK cage has three(3) x-ray markers made of tantalum for ease of visualization on the radiographs. Angled shape for lordotic curve and anatomic shape is available to allow maximum preservation of bony endplate with this system and teeth on the surfaces ensure enough contact with bony endplate, which prevents subsidence of the cage into the vertebral body when the teeth increase the anchoring and prevent slipping or expulsion.
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)
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 and dynamic compression, static and dynamic torsion, static subsidence and static expulsion) was conducted in accordance with ASTM F2077, and ASTM F2267. Mechanical testing confirmed 4CIS® Marlin ACIF Cage System demonstrated equivalent performance to the cited predicate device under the same test conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SYNTHES ACIS/VERTEBRAL SPACER CR (K120275, Primary), Endoskeleton® TC (K100889, Additional), PATRIOT SPACERS: COLONIAL ACDF(K072991, Additional), Phantom™ Plus (K082801, Additional), TRYPTIK Ca (K091873, Additional)
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2017
Solco Biomedical Co., Ltd. % Hwi Joon Park Manager First Gold Corp. 14110 Dallas Pkwy, Suite 135 Dallas, Texas 75254
Re: K162402
Trade/Device Name: 4CIS® Marlin ACIF Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 11, 2016 Received: January 17, 2017
Dear Mr. Park:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K162402
Device Name 4CIS® Marlin ACIF Cage System
Indications for Use (Describe)
4CIS® Marlin ACIF Cage System is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from 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. The 4CIS® Marlin ACIF Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous 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)
| X Prescription Use (Part 21 CEB 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CER 801 Subpart C) |
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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 JOON, PARK
14110 Dallas Pkwy Suite 135, Dallas, Texas 75254 USA
Phone: +1-972-247-2486
Fax: +1-972-247-2413 |
| Submission Date | Aug 23, 2016 |
| Trade / Proprietary name | 4CIS® Marlin ACIF Cage System |
| 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 | SYNTHES ACIS/VERTEBRAL SPACER CR
(K120275, Primary)
Endoskeleton® TC (K100889, Additional)
PATRIOT SPACERS: COLONIAL ACDF(K072991, Additional)
Phantom™ Plus (K082801, Additional)
TRYPTIK Ca (K091873, Additional)
The predicate devices have not been subject to a design related recall. |
| Description of Device | 4CIS® Marlin ACIF cages are hollow, generally rectangular box
shape made either from poly-ether-ether-ketone [PEEK-OPTIMA®
LT1 (Invibio, Inc., West Conshohocken, PA USA) / VESTAKEEP®
i4R (Evonik Industries, Essen Germany)] or Titanium alloy
according to ASTM F2026(PEEK), F136(64ELI), F560(Tantalum).
The cages are available in a variety of sizes and geometric options to |
| | fit the anatomical needs of a wide variety of patients. |
| | The device is filled with a bone graft material and inserted into the
intervertebral body space of the cervical spine through an anterior
cervical approach. As the design requirements, this cage design
maintains the spacing between two vertebral bones following
discectomy until fusion occurs. |
| | Each PEEK cage has three(3) x-ray markers made of tantalum for
ease of visualization on the radiographs. |
| | Angled shape for lordotic curve and anatomic shape is available to
allow maximum preservation of bony endplate with this system and
teeth on the surfaces ensure enough contact with bony endplate,
which prevents subsidence of the cage into the vertebral body when
the teeth increase the anchoring and prevent slipping or expulsion. |
| Indication for Use | 4CIS® Marlin ACIF Cage System is indicated for use in cervical
intervertebral body fusion procedures in skeletally mature patients with
degenerative disc disease (DDD) at the levels from 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.
The 4CIS® Marlin ACIF Cage System 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 | Indication for Use
The subject 4CIS® Marlin ACIF Cage System and all the predicates
have similar indications for use statements. |
| | Materials
The predicate subject device is composed of the same material as the
predicate devices have conforming to recognized industry standards for
permanent implants. |
| | Design Features/Functions
The subject 4CIS® Marlin ACIF Cage System and cited predicate
devices share similar basic design features and functions. |
| | Dimensions
The subject 4CIS® Marlin ACIF Cage System is dimensionally similar
to cited predicate devices. |
| | Sterilization
The subject 4CIS® Marlin ACIF Cage System and cited predicate
devices are provided sterile and non-sterile for single use only. |
| | Performance Specification |
| | Mechanical testing confirmed 4CIS® Marlin ACIF Cage System
demonstrated equivalent performance to the cited predicate device under
the same test conditions. |
| Performance Data | Mechanical testing (static and dynamic compression, static and dynamic
torsion, static subsidence and static expulsion) was conducted in
accordance with ASTM F2077, and ASTM F2267.
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 | Based on the provided performance data, the subject device is
substantially equivalent to the referenced predicate devices. |
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