(157 days)
Not Found
No
The summary describes a physical implant (a lumbar fusion cage) made of PEEK and titanium. There is no mention of software, algorithms, or any technology that would process data or make decisions, which are characteristic of AI/ML. The "radiographic studies" mentioned are used for diagnosis, not as input for the device itself.
Yes
Explanation: The device is intended for the treatment of degenerative disc disease and is implanted in the spine, which aligns with the definition of a therapeutic device.
No
This device is an implantable fusion cage used in surgical treatment for degenerative disc disease, not a device used to diagnose the condition. The input mentions "radiographic studies" as a way to confirm disc degeneration, but this refers to information used to determine the patient's condition, not a function of the device itself.
No
The device description clearly states it is a physical implant made of PEEK and Titanium alloy, intended for surgical implantation. It also describes physical testing performed on the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The AnyPlus® PEEK Lumbar Fusion Cage is an implantable surgical device. Its purpose is to provide structural support and facilitate fusion in the spine during surgery. It is not used to analyze biological samples.
- Intended Use: The intended use clearly describes its application in surgical procedures for treating degenerative disc disease, not for diagnostic testing of biological specimens.
- Device Description: The description focuses on the materials and design of the implant itself, not on components or processes related to analyzing biological samples.
The information about "radiographic studies" in the "Input Imaging Modality" section refers to imaging techniques used to assess the patient's condition and the placement of the device, not to the device itself performing a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of nonoperative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
AnyPlus® PEEK Lumbar Fusion Cage device is intended for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
Product codes
MAX
Device Description
The GS Medical AnyPlus PEEK Lumbar Cage device consists 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 OPTIMA LT1) (Manufacturer - INVIBIO) body with the x-ray markers made of Titanium alloy (Ti-6Al-4V). This submission includes the addition of sizes to the model ALIF devices and a revision of the shapes of the TLIF model and the PLIF model to accommodate surgeons using a Direct Lateral Interbody Fusion (DLIF) surgical approach.
The GS Medical AnyPlus PEEK Lumbar Cage devices are designed for restoring the height of the intervertebral space after resection of the disc. The AnyPlus PEEK Lumbar Cage devices 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 Titanium alloy (Ti-6Al-4V). The intended use, technological characteristics, mode of action and materials of construction are the same as those of the referenced predicate devices
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal levels from 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)
The GS Medical AnyPlus PEEK Lumbar Cage 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
K 111354
OCT 1 7 2011
6. 510(k) Summary
| Manufacturer: | GS Medical Co. Ltd.
12F Kolon Digital Tower Aston,
505-14 Gasan-Dong
Geumcheon-gu, Seoul, Korea |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | October 14, 2011 |
| Submitted by: | GS Medical Co. Ltd |
| Company Contact | Dong Young Kim
+82-2-2082-777
+82-2-2082-7778 (FAX) |
| US Agent Information | Orgenix LLC
Mr. Donald W. Guthner
111 Hill Road
Douglassville, PA 19518
+1-646-460-2984
+1-484-363-5879 (FAX) |
| Classification Name: | Intervertebral Body Fusion Device |
| Common/Usual Name: | Intervertebral Body Fusion Device, IBF Device |
| Proprietary Name: | AnyPlus PEEK ALIF Lumbar Fusion Cage
AnyPlus PEEK DLIF Lumbar Fusion Cage |
| Performance standards: | The GS Medical AnyPlus PEEK Lumbar Cage was non-clinically
tested according to the ASTM 2077-03 and ASTM F2267-04
performance standards. |
| Classification no .: | 21 CFR 888.3080
MAX - Intervertebral body fusion device
Class II |
| Substantial Equivalence: | Substantial equivalence for the GS Medical AnyPlus PEEK
Lumbar Cage is based on its similarities in indications for use,
design features, operational principles and material composition
when compared to the predicate devices cleared under the
following submissions:
. K100516 AnvPluc DEEK Lumber Cago |
• K100516 AnyPlus PEEK Lumbar Cage
.
if
1
The subject device is substantially equivalent to similar previously Predicate Devices: cleared devices.
Device Description: The GS Medical AnyPlus PEEK Lumbar Cage device consists 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 OPTIMA LT1) (Manufacturer - INVIBIO) body with the x-ray markers made of Titanium alloy (Ti-6Al-4V). This submission includes the addition of sizes to the model ALIF devices and a revision of the shapes of the TLIF model and the PLIF model to accommodate surgeons using a Direct Lateral Interbody Fusion (DLIF) surgical approach.
Intended Use: The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic These patients should have had six months of nonstudies. operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
Summary of The GS Medical AnyPlus PEEK Lumbar Cage devices are designed for restoring the height of the intervertebral space after Technological resection of the disc. The AnyPlus PEEK Lumbar Cage devices Characteristics 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 Titanium alloy (Ti-6Al-4V). 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 GS Medical AnyPlus PEEK Lumbar Cage 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.
Conclusion The information discussed above demonstrates requested changes to the GS Medical PEEK Lumbar Cage device is effective and performs as well as or better than the predicate devices.
2
Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of an eagle or bird in flight, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN..." are arranged around the left side of the emblem in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 7 2011
GS Medical Co., Ltd. % Orgenix LLC Mr. Donald W. Guthner 111 Hill Road Douglassville, Pennsylvania 19518 ﺮ ﺍﻟ
Re: K111354
Trade/Device Name: GS Medical AnyPlus PEEK Lumbar Fusion Cages Regulation Number: 21 CFR 888.3080 . Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 19, 2011 Received: September 21, 2011
Dear Mr. Guthner:
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
3
Page 2 - Mr. Donald W. Guthner
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Erine Keith
Sa Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5. Indications for Use
510(k) Number (if known): K111354
Device Name: GS Medical AnyPlus PEEK Lumbar Fusion Cages
AnyPlus® PEEK Lumbar Fusion Cage device is intended for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KII 354 510(k) Number_