(86 days)
The GPS™, G Surgical Anterior Cervical Plate System is intended for use in anterior cervical decompression and fusion (ACDF) surgery at levels C2-C7. The system is indicated for temporary stabilization of the anterior spine during the development of cervical fusions in skeletally mature patients with the following indications:
- Degenerative Disc Disease (as defined by neck pain of the discogenic origin with . degeneration of disc confirmed by patient history and radiographic studies)
- Trauma (including fractures) .
- Tumors .
- Deformities or curvatures (including kyphosis, lordosis, or scoliosis) .
- Pseudarthrosis .
- . Failed previous fusion
- . Spondylolisthesis
- . Spinal Stenosis
The GPS™ G Surgical Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, bone screws, locking screws, and associated instruments. Fixation is provided by bone screws, of various lengths, inserted into the vertebral body of the cervical spine using an anterior approach. The GPS™ G Surgical Anterior Cervical Plate System implant components are made from titanium alloy described by ASTM F136 and supplied non sterile. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the GPS ™, G Surgical Pedicle System implants.
The provided text describes the GPS™ G Surgical Anterior Cervical Plate System, an anterior cervical plate system intended for use in spinal fusion surgery. This submission is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than proving de novo safety and effectiveness through clinical trials.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|
| Static Compression (ASTM F1717) | Adheres to ASTM F1717. The test results demonstrate the GPS™ G Surgical Anterior Cervical Plate System is safe and effective and adequate for the intended use. (Specific quantitative values are not provided in the summary). |
| Dynamic Compression (ASTM F1717) | Adheres to ASTM F1717. The test results demonstrate the GPS™ G Surgical Anterior Cervical Plate System is safe and effective and adequate for the intended use. (Specific quantitative values are not provided in the summary). |
| Static Torsion (ASTM F1717) | Adheres to ASTM F1717. The test results demonstrate the GPS™ G Surgical Anterior Cervical Plate System is safe and effective and adequate for the intended use. (Specific quantitative values are not provided in the summary). |
| Substantial Equivalence | Demonstrated through non-clinical testing comparing mechanical performance to predicate devices (K030866 Synthes CSLP, K000536 Synthes CSLP, K021461 Medtronic Atlantis Vision®). The results of non-clinical testing demonstrate that the mechanical performance of the GPS™ G Surgical Anterior Cervical Plate System is equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of devices tested. The document refers to "Performance testing... included static compression, dynamic compression and static torsion in accordance with ASTM F1717." ASTM F1717 specifies testing methodologies, including sample sizes (e.g., typically a minimum of 6 specimens per test condition for mechanical tests), but the exact number of units tested for this specific device is not disclosed in the summary.
- Data Provenance: The testing was "non clinical testing." The document does not specify the country of origin of the test data or the location where the testing was performed. It is retrospective in the sense that the testing was conducted on manufactured devices to assess their mechanical properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This device approval is based on non-clinical mechanical performance testing, not human interpretation of data where "ground truth" would be established by medical experts (e.g., radiologists). Therefore, this question is not applicable in the context of this 510(k) submission.
4. Adjudication Method for the Test Set
- Not applicable. The "test set" here refers to the mechanical performance testing of the device itself, not to a set of medical images or patient cases requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No MRMC comparative effectiveness study was done. This 510(k) submission did not involve clinical testing or AI assistance. It focused on demonstrating substantial equivalence based on mechanical performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No standalone algorithm performance study was done. This device is a surgical implant, not an AI or diagnostic algorithm.
7. The Type of Ground Truth Used
- For the mechanical performance testing, the "ground truth" is defined by the objective measurements obtained from standardized mechanical tests (static compression, dynamic compression, static torsion) as specified by ASTM F1717. The "truth" is whether the device's mechanical properties meet predefined acceptance criteria (implicitly, by being comparable to predicate devices and demonstrating safety and effectiveness for intended use) under these controlled testing conditions.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical implant and does not involve machine learning or a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device is a mechanical implant and does not involve machine learning or a training set.
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K103070
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510(k) Summary
(as required by 21 CFR 807.92)
Submitted By:
Donald Grafton G Surgical Co., Ltd. 4218 Skvwav Dr Naples, FL 34112 Ph 239 919 4895 Fax 239 455 8988
JAN 1 2 2011
4
Date:
Oct. 4, 2010
Sponsor:
G Surgical Co., Ltd. 152 Soi Ramkhamhaeng 138 Sapansung, Bangkok Thailand 10240
Trade Name: Common Name: Classification Name: Device Class:
Device/Product Code(s):
GPS ™, Anterior Cervical Plate System Anterior Cervical System Spinal Intervertebral Body Fixation Orthosis FDA proposed classification as Class II (888.3060) following Orthopedic and Rehabilitation Device Advisory Review, for the requested indications. Anterior Cervical Plates (KWQ) 21 CFR § 888.3060
| Predicate Devices: | K030866 Synthes CSLP | April 18, 2003 |
|---|---|---|
| K000536 Synthes CSLP | May 15, 2000 | |
| K021461 Medtronic Atlantis Vision® | July 22, 2002 |
Device Description: The GPS™ G Surgical Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, bone screws, locking screws, and associated instruments. Fixation is provided by bone screws, of various lengths, inserted into the vertebral body of the cervical spine using an anterior approach. The GPS™ G Surgical Anterior Cervical Plate System implant components are made from titanium alloy described by ASTM F136 and supplied non sterile. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the GPS ™, G Surgical Pedicle System implants.
Indications for Use: The GPS™, G Surgical Anterior Cervical Plate System is intended for use in anterior cervical decompression and fusion (ACDF) surgery at levels C2-C7. The system is indicated for temporary stabilization of the anterior spine during the development of cervical fusions in skeletally mature patients with the following indications:
- Degenerative Disc Disease (as defined by neck pain of the discogenic origin with . degeneration of disc confirmed by patient history and radiographic studies)
- Trauma (including fractures) .
- Tumors .
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K103070
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- Deformities or curvatures (including kyphosis, lordosis, or scoliosis) .
- Pseudarthrosis .
- . Failed previous fusion
- . Spondylolisthesis
- . Spinal Stenosis
Warning: The device is not intended for screw attachments or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Performance Data: Performance testing was performed on the GPS™ G Surgical Anterior Cervical Plate System included static compression, dynamic compression and static torsion in accordance with ASTM F1717. The test results demonstrate the GPS™ G Surgical Anterior Cervical Plate System is safe and effective and adequate for the intended use. No clinical testing was performed.
Substantial Equivalence: The GPS™ G Surgical Anterior Cervical Plate System is equivalent to the predicate devices in design, function and indications of use. The results of non clinical testing demonstrate that the mechanical performance of the GPS™ G Surgical Anterior Cervical Plate System is equivalent to the predicate devices. Thus the GPS™ G Surgical Anterior Cervical Plate System is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, and three horizontal lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
G Surgical Co., Ltd. % Mr. Donald Grafton 152 Soi Ramkhamhaeng 138 Sapansung, Bangkok Thailand 10240
JAN 1 2 2011
Re: K103070
Trade/Device Name: GPS™, G Surgical Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 16, 2010 Received: December 17, 2010
Dear Mr. Grafton:
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
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Page 2 - Mr. Donald Grafton
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, "Mistranding 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/Resourcesfor-You/Industry/default.htm.
Sincerely yours,
A
B
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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K103070
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INDICATIONS FOR USE
Device Name GPS™, G Surgical Anterior Cervical Plate System
JAN 1 2 2011
દ્વા
Indications for Use: The GPS™, G Surgical Anterior Cervical Plate System is intended for use in anterior cervical decompression and fusion (ACDF) surgery at levels C2-C7. The system is indicated for temporary stabilization of the anterior spine during the development of cervical fusions in skeletally mature patients with the following indications:
- Degenerative Disc Disease (as defined by neck pain of the discogenic origin with . degeneration of disc confirmed by patient history and radiographic studies)
- Trauma (including fractures) .
- Tumors
- Deformities or curvatures (including kyphosis, lordosis, or scoliosis) .
- Pseudarthrosis �
- � Failed previous fusion
- Spondylolisthesis .
- Spinal Stenosis .
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
x AND/OR Over the Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_ K103070
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.