(199 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the PEEK cage for spinal fusion, with no mention of AI or ML for image analysis, diagnosis, or treatment planning.
Yes
The device is described as "intervertebral body fusion devices" used to "facilitate intervertebral body fusion in the cervical spine" for patients with "degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms." This directly indicates a therapeutic purpose by treating a medical condition and restoring function.
No
Explanation: The device, the AnyPlus® Cervical PEEK Cage System, is described as an intervertebral body fusion device used to restore height and stabilize the cervical spine. Its purpose is treatment through fusion, not diagnosis of a condition.
No
The device description explicitly states it consists of implants made of PEEK and Tantalum, which are physical hardware components, not software.
Based on the provided information, the AnyPlus® Cervical PEEK Cage System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The AnyPlus® Cervical PEEK Cage System is an implantable medical device used in surgery to facilitate spinal fusion. It is a physical device inserted into the body, not a tool for analyzing biological samples.
The description clearly states its purpose is to restore intervertebral space height and facilitate fusion in the cervical spine. This is a surgical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The AnyPlus® Cervical PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. AnyPlus® Cervical PEEK cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. AnyPlus® Cervical PEEK cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
ODP
Device Description
The AnyPlus® Cervical PEEK Cage System is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® Cervical PEEK Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The intervertebral body fusion devices are made of poly-ether-ether-ketone (PEEK Optima LT1) body with the X-ray (radio-opaque) markers made of Tantalum. The AnyPlus® Cervical PEEK Cage System are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® Cervical PEEK Cage System is supplied non-sterile and is intended for single use only. AnyPlus® Cervical PEEK Cage System is designed for interbody stabilization of the cervical spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Cervical spine at the C3 to C7 disc levels
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
Non-Clinical Testing: The AnyPlus® Cervical PEEK cages were tested according to the ASTM 2077, specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing Expulsion Testing and Static Subsidence testing under Axial Compression, per ASTM 2267. All performance test results were equivalent to or higher than a legally marketed predicate device.
Clinical Testing: No clinical testing was performed.
Key Metrics
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2016
GS Medical Company, Ltd. % Mr. Barry E. Sands President RQMIS, Incorporated 29 Water Street, Suite 305 Newburyport, Massachusetts 01950
Re: K153517
Trade/Device Name: AnyPlus® Cervical PEEK Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: May 26, 2016 Received: May 27, 2016
Dear Mr. Sands:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) 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" (21CFR 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 yours,
Lori A. Wiggins -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
510(k) Number (if known) K153517
Device Name AnyPlus® Cervical PEEK Cage System
Indications for Use (Describe)
The AnyPlus® Cervical PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. AnyPlus® Cervical PEEK cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. AnyPlus® Cervical PEEK cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
| 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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510(k) SUMMARY
GS Medical Co., Ltd.
AnyPlus® Cervical PEEK Cage System
| Manufacturer: | GS Medical Co., Ltd.
90, Osongsaengmyeong 4-ro
Osong-eup
Cheongwon-gun
Chungcheongbuk-do
363-951 Korea |
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | March 20, 2016 |
| Submitted by: | GS Medical Co., Ltd |
| Company Contact | Marcin Niemiec |
| US Agent Information
Official Correspondent | RQMIS Inc.
Mr. Barry E. Sands
110 Haverhill Road, Suite 526
Amesbury, MA 01913
Ph: 978-358-7307
www.rqmis.com |
| Proprietary Name: | AnyPlus® Cervical PEEK Cage System |
| Performance standards: | The AnyPlus® Cervical PEEK Cage System was non-clinically tested
according to the ASTM 2077-11 and ASTM F2267-04 performance
standards. |
| Regulation:
Common/Usual Name:
Classification name:
Review Panel:
Product Code:
Device Class: | 21 CFR 888.3080
Cervical Spinal Fusion Device, IBF Device
Intervertebral body fusion device – Cervical
Orthopedic
ODP
Class II |
| Substantial Equivalence: | Substantial equivalence for the AnyPlus® Cervical PEEK Cage System is
based on its similarities in indications for use, design features,
operational principles and material composition when compared to the
predicate devices. |
| Predicate Devices: | K082801 US Spine Phantom Cervical Cage (primary)K091873 SpineArt Tryptik Cervical Cage (secondary) |
| | The subject device is substantially equivalent to similar previously
cleared devices. |
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| Device Description: | The AnyPlus® Cervical PEEK Cage System is designed for restoring the
height of the intervertebral space after resection of the disc. AnyPlus®
Cervical PEEK Cage System consists of implants available in various
heights and lordotic configurations with an open architecture to accept
packing of bone graft material. The intervertebral body fusion devices
are made of poly-ether-ether-ketone (PEEK Optima LT1) body with the
X-ray (radio-opaque) markers made of Tantalum. The AnyPlus® Cervical
PEEK Cage System are radiolucent allowing X-ray visualization to verify
device placement. AnyPlus® Cervical PEEK Cage System is supplied non-
sterile and is intended for single use only. AnyPlus® Cervical PEEK Cage
System is designed for interbody stabilization of the cervical spine. |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The AnyPlus® Cervical PEEK Cage System is indicated for use in
skeletally mature patients with degenerative disc disease (DDD) of the
cervical spine with accompanying radicular symptoms at one disc level.
DDD is defined as discogenic pain with degeneration of the disc
confirmed by patient history and radiographic studies. AnyPlus®
Cervical PEEK cages are used to facilitate intervertebral body fusion in
the cervical spine at the C3 to C7 disc levels using autograft bone.
AnyPlus® Cervical PEEK cages are to be used with supplemental fixation.
Patients should have at least six (6) weeks of non-operative treatment
prior to treatment with an intervertebral cage. |
| Summary of Technological
Characteristics | The AnyPlus® Cervical PEEK cages are designed for restoring the height
of the intervertebral space after resection of the disc. The AnyPlus®
Cervical PEEK cages consist of implants available in various heights and
lordotic configurations with an open architecture to accept packing of
bone graft material. The implants are made of polyether-ether-ketone
(PEEK) body with the x-ray markers made of Tantalum. The intended
use, technological characteristics, mode of action and materials of
construction are the same as those of the referenced predicate devices |
| Non-Clinical Testing | The AnyPlus® Cervical PEEK cages were tested according to the ASTM
2077, specifically, Static and Dynamic Axial Compression, Static and
Dynamic Compression-Shear Testing, Static and Dynamic Torsion
Testing Expulsion Testing and Static Subsidence testing under Axial
Compression, per ASTM 2267. All performance test results were
equivalent to or higher than a legally marketed predicate device. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The AnyPlus® Cervical PEEK cages have the same intended use and
similar indications, principles of operation, and technological
characteristics as the predicate devices. The minor differences in the
designs do not raise any new questions of safety or effectiveness.
Performance data demonstrates that the AnyPlus® Cervical PEEK cages
are as safe and effective as the predicate devices. Thus, the AnyPlus®
Cervical PEEK cages are substantially equivalent to the predicate
devices. |