(101 days)
Not Found
No
The document describes a mechanical implant system and surgical instruments, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is intended to treat conditions such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumors, pseudoarthrosis, and failed previous fusion, which are all medical conditions.
No
Explanation: The MVP Cervical Plate System is described as a "multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments" intended for "anterior cervical fixation." It is an implantable device used to stabilize the cervical spine as an adjunct to fusion, not for diagnosis.
No
The device description explicitly states it is a "multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments," all of which are physical hardware components.
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 MVP Cervical Plate System is for "anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion." This describes a surgical implant used to stabilize the spine, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details plates, screws, and surgical instruments made of titanium and stainless steel. These are physical components used in surgery, not reagents, analyzers, or other materials typically associated with IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MVP Cervical Plate System is a surgical implant used for structural support and stabilization.
N/A
Intended Use / Indications for Use
The MVP Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications:
• Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- · Spondylolisthesis
- · Trauma (including fracture or dislocation)
- · Spinal Stenosis
- · Deformities or curvatures (kyphosis, lordosis, or scoliosis)
- Tumors
- · Pseudoarthrosis
- Failed Previous Fusion
Product codes (comma separated list FDA assigned to the subject device)
KWO
Device Description
The MVP Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The MVP Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136). The Instruments in the MVP Cervical Plate System are supplied non-sterile, are reusable, and are fabricated from titanium alloy Ti-6Al-4V or stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior cervical fixation (C2-C7)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
Testing and analyses performed indicate that the MVP Cervical Plate System is as mechanically sound as the predicate device. Testing included static compression, dynamic compression, and torsional testing per ASTM F1717-15, as well as reprocessing instruction validation. The results demonstrate that the acceptance criteria defined by predicate device performance were met.
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
§ 888.3060 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
May 13, 2019
GS Medical Co., Ltd. % Ms. Manjusha Bharadwaj Senior Regulatory/Quality Consultant RQMIS, Inc. 110 Haverhill Road Amesbury, Massachusetts 01913
Re: K190170
Trade/Device Name: MVP Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: March 18, 2019 Received: March 20, 2019
Dear Ms. Bharadwaj:
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
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190170
Device Name MVP Cervical Plate System
Indications for Use (Describe)
The MVP Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications:
• Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- · Spondylolisthesis
- · Trauma (including fracture or dislocation)
- · Spinal Stenosis
- · Deformities or curvatures (kyphosis, lordosis, or scoliosis)
- Tumors
- · Pseudoarthrosis
- Failed Previous Fusion
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
GS Medical MVP Cervical Plate System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
GS Medical Co., Ltd. 90, Osongsaengmyeong 4-Ro Osong-Eup, Cheongwon-Gun, KR 363-951 Phone: 949-308-6385
Contact Person: Manjusha Bharadwaj Senior Regulatory/Quality Consultant RQMIS, Inc. 110 Haverhill Road Amesbury, MA 01913 Phone: 978-358-7307 Fax: 978-477-0206 Email: manjushabharadwaj@rqmis.com
Date Prepared: January 11, 2019
Name of Device and Name/Address of Sponsor
Trade Name: MVP Cervical Plate System GS Medical Co., Ltd. 90, Osongsaengmyeong 4-Ro Osong-Eup, Cheongwon-Gun, KR 363-951
Common or Usual Name
Device Type: Anterior Cervical Plating System
Classification Name: 21 CFR 888:3060 Spinal Intervertebral Body Fixation Orthosis
Orthopedics, Product Code KWQ
4
Reason for 510(k) Submission
GS Medical is submitting this traditional 510(k) to gain clearance for the MVP Cervical Plate System. This device includes plates and screws of various sizes, as well as associated instruments. GS Medical believes that the MVP Cervical Plate System is substantially equivalent to the following:
- . Synthes Anterior CSLP System (K030866) – primary
- NUVASIVE HELIX MINI ACP SYSTEM (K073275) -- additional
- . Depuy UNIPLATE 2 Anterior Cervical Plate System (K100070) - additional
Intended Use / Indications for Use
The MVP Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications:
- . Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- . Trauma (including fracture or dislocation)
- . Spinal stenosis
- . Deformities or curvatures (kyphosis, lordosis, or scoliosis)
- Tumors
- Pseudoarthrosis
- Failed previous fusion
Technological Characteristics
The MVP Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The MVP Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136). The Instruments in the MVP Cervical Plate System are supplied non-sterile, are reusable, and are fabricated from titanium alloy Ti-6Al-4V or stainless steel.
Performance Data
Testing and analyses performed indicate that the MVP Cervical Plate System is as mechanically sound as the predicate device. Testing included static compression, dynamic compression, and torsional testing per ASTM F1717-15, as well as reprocessing instruction validation. The results demonstrate that the acceptance criteria defined by predicate device performance were met.
Substantial Equivalence
The intended use and technological characteristics (e.g., design, materials, principle of operations) of the MVP Cervical Plate System is substantially equivalent to the primary predicate Synthes Anterior CSLP System (K030866). Performance data demonstrates that the MVP Cervical Plate System is substantially equivalent to the Synthes Anterior CSLP System (K030866).