(157 days)
Not Found
No
The 510(k) summary describes a physical implant (a PEEK cage) used for spinal fusion. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on mechanical properties and biocompatibility, not algorithmic performance.
Yes.
The device is used to facilitate intervertebral body fusion in patients with degenerative disc disease, which describes a therapeutic rather than diagnostic function.
No
Explanation: The device is an intervertebral cage system designed to facilitate spinal fusion, not to diagnose a medical condition. Its function is therapeutic.
No
The device description explicitly states the device is made of physical materials (PEEK and Tantalum) and is an implantable cage system, which is a hardware device.
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 to facilitate intervertebral body fusion in the cervical spine. This is a therapeutic and structural function within the body.
- Device Description: The description details a physical implant made of PEEK and Tantalum, designed to restore disc height and accept bone graft. This is a medical device, not a diagnostic tool.
- No mention of in vitro testing: The document does not describe any process of testing samples (like blood, urine, tissue) outside of the body to diagnose a condition or provide information about a patient's health status.
- Performance Studies: The performance studies focus on the mechanical properties and safety of the implant itself (compression, shear, torsion, expulsion, subsidence), not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The GS Medical AnyPlus® 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. GS Medical AnyPlus® PEEK Cage System are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical AnyPlus® PEEK Cage System are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The GS Medical AnyPlus® PEEK Cage System device is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® PEEK Cage System device 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® PEEK Cage System devices are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® PEEK Cage System device is supplied sterile and non-sterile and is intended for single use only. AnyPlus® 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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The GS Medical AnyPlus® PEEK Cage System devices 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. Pyrogen limit specifications were tested and met on "worst-case" model, complying with FDA guidance an specifications.
No clinical testing was performed.
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.
Not Found
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 10, 2020
GS Medical Co., Ltd. % Mr. Barry Sands President and Founder RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913
Re: K200592
Trade/Device Name: The GS Medical AnyPlus® PEEK Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: July 10, 2020 Received: July 15, 2020
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. 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,
Brent Showalter, Ph.D. Acting Assistant Director 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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K200592
Device Name GS Medical AnyPlus® PEEK Cage System
Indications for Use (Describe)
The GS Medical AnyPlus® 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. GS Medical AnyPlus® PEEK Cage System are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical AnyPlus® PEEK Cage System are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative 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® PEEK Cage System
| Manufacturer: | GS Medical Co.,Ltd.
90, Osongsaengmyeong 4-ro
Osong-eup
Cheongwon-gun
Chungcheongbuk-do
363-951 Korea | |
|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Date: | March 2, 2020 | |
| Submitted by: | GS Medical Co.,Ltd | |
| Company Contact | Andrea Watt
+1 949-380-6385
awatt@gsmedical.com | |
| US Agent Information
Official Correspondent | RQMIS Inc.
Mr. Barry E. Sands
110 Haverhill Rd, Suite 526
Amesbury, MA 01913
Ph: 978-358-7307
barrysands@rqmis.com | |
| Proprietary Name: | The GS Medical AnyPlus® PEEK Cage System | |
| Performance standards: | The GS Medical AnyPlus® 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 GS Medical AnyPlus® 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. | |
| Primary Predicate Device: | K153517 GS Medical AnyPlus® Cervical PEEK Cage
The subject device is substantially equivalent to similar previously cleared devices. | |
| Device Description: | The GS Medical AnyPlus® PEEK Cage System device is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® PEEK Cage System device 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® PEEK Cage System devices are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® PEEK Cage System device is supplied sterile and non-sterile and is intended for single use only. AnyPlus® PEEK Cage System is designed for interbody stabilization of the cervical spine. | |
| Intended Use: | The GS Medical AnyPlus® 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. GS Medical The GS Medical AnyPlus® PEEK Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical The GS Medical AnyPlus® PEEK Cage System is 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 GS Medical AnyPlus® PEEK Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc. The GS Medical AnyPlus® PEEK Cage System device 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. | |
| Device Materials | Material | Standard |
| | Polyether-ether-ketone (PEEK) | ASTM F2026:17 |
| | Unalloyed Tantalum | ASTM F560-17 |
| | Wrought Stainless Steel | ASTM F899-19 |
| Non-Clinical Testing | The GS Medical AnyPlus® PEEK Cage System devices 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. Pyrogen limit specifications were tested and met on
"worst-case" model, complying with FDA guidance an
specifications. | |
| Clinical Testing | No clinical testing was performed. | |
| Conclusion | The GS Medical AnyPlus® PEEK Cage System has the same
intended use and similar indications, principles of operation,
and technological characteristics as the predicate device. The
minor differences in the designs do not raise any new
questions of safety or effectiveness. Performance data
demonstrates that the AnyPlus® Cervical PEEK Cage System
are as safe and effective as the predicate device. Thus, the
AnyPlus® Cervical PEEK Cage System is substantially
equivalent to the predicate device. | |
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