(347 days)
No
The device description focuses on the mechanical properties and design of metal plates and screws for bone fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is an orthopedic implant for fixation of fractures and osteotomies, which is a structural support device, not a therapeutic device.
No
The device is a plating system used for fixation of fractures and osteotomies, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a system of machined metal plates and screws, which are physical hardware components intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is a surgical implant designed for the physical fixation of bone fractures. It is a mechanical device used in vivo (within the body) during surgery.
- Intended Use: The intended use is for "fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones." This is a structural and mechanical function, not a diagnostic one based on analyzing biological samples.
The description clearly indicates a surgical implant used to stabilize bones, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
GPC Variable Angle Locking Two Column Volar Distal Radius Plates are machined metal plates designed for fixation of various fracture modes of the distal portion of the Variable Angle Locking Two Column Volar Distal Radius Plates allow fragment-specific fracture fixation by providing the flexibility to lock screws in the head or shaft of the plate in trajectories that can diverge from the central axis of the plate hole. The variable angle locking mechanism improves the plate-screw construct stability. GPC Variable Angle Locking Two Column Volar Distal Radius Plates are manufactured using titanium material for surgical implant applications.
Following are the types of the GPC Variable Angle Locking Two Column Volar Distal Radius Plates:
- Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 22 mm, 6 Head Holes (with option of Left and Right Variants)
- Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 25.5 mm, 7 Head Holes (with option of left and right variants)
- Variable Angle Locking Two Column Volar Distal Radius Plate- Narrow, Width 19.5 mm, 6 Head Holes (with option of left and right variants)
Corresponding Screws for fixation: - Variable Angle Locking Screw 2.4 mm, Star drive Lengths: 6mm to 30mm in 2mm increments
- FixLOCK Self-Tapping Screw 2.4 mm, Star drive Length 6mm to 30mm in 2mm increments
- Self-Tapping Cortex Screw 2.7 mm, Star drive Length: 12mm to 24mm
These implants are supplied non-sterile, the products have to be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius and other small bones.
Indicated Patient Age Range
adult patients only.
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 device performance of GPC Variable Angle Locking Two Column Volar Distal Radius Plating System has been demonstrated against following applicable standards
For GPC Variable Angle Locking Two Column Volar Distal Radius Plates:
- The testing performed as per ASTMF382
Static Four Point Bend Test: Conforms
Bending Fatique Properties: Conforms
For Bone Screws:
The Testing Performed As per ASTMF 543: Torsional Properties: Conforms, Driving Torque : Conforms, Pull-out Test: Conforms
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.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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January 7, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GPC Medical Limited Vikas Narang Director GPC Square, M-Block, DDA LSC, Vikas Puri, New Delhi New Delhi, Delhi 110018 India
Re: K210198
Trade/Device Name: GPC 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: December 6, 2021 Received: December 6, 2021
Dear Vikas Narang:
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210198
Device Name
Indications for Use (Describe)
| 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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K210198 Page 1 of 4
Premarket Notification 510(k) Summary as required by Section 807.92
| Submitter's Name: | GPC Medical Ltd. |
|---|---|
| Address: | Office : GPC Square, M-Block, DDA, LSC, Vikas Puri New Delhi, |
| 110018 INDIA. | |
| Factory : Plot C-3, Sec B-1, UPSIDC, Trans Delhi Signature City, | |
| Loni, Ghaziabad, UP 201102 | |
| Contact Person Name: | Mr. Vikas Narang |
| Title: | Director |
| Phone Number: | +91-9810638797 |
| Dated: | 25-05-2021 |
Proprietary Name:
-
Name of the Device: GPC Variable Angle Locking Two Column Volar Distal Radius Plating . System
Common or Usual Name: -
Orthopaedic Bone Plates
-
. Orthopaedic Bone Screws
Classification Name:
- PLATE,FIXATION,BONE
- SCREW,FIXATION, BONE .
Product Code: HRS (Primary), HWC
Device Class: Il
- Review Pane: Orthopaedic
Regulation Number: 21CFR888.3030 (Primary) and 21CFR888.3040
Device Details:
- GPC Variable Angle Locking Two Column Volar Distal Radius Plates are manufactured in various ● shapes and sizes. The GPC Variable Angle Locking Two Column Volar Distal Radius Plates are fixed with corresponding sizes of locking screws.
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A3) Identification of the Predicate Device
Following are the predicate device 510(k) with which we are declaring substantial equivalence:
Primary predicate: Synthes (USA) 2.4mim VA-LCP Two-Column Narrow Volar Distal (K092556)
Additional Predicate: Synthes 2.4mm Variable Angle LCR Volar Rim Distal Radius System (K110125)
Reference Device: Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plate (K083694)
A4). A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device
GPC Variable Angle Locking Two Column Volar Distal Radius Plates are machined metal plates designed for fixation of various fracture modes of the distal portion of the Variable Angle Locking Two Column Volar Distal Radius Plates allow fragment-specific fracture fixation by providing the flexibility to lock screws in the head or shaft of the plate in trajectories that can diverge from the central axis of the plate hole. The variable angle locking mechanism improves the plate-screw construct stability. GPC Variable Angle Locking Two Column Volar Distal Radius Plates are manufactured using titanium material for surgical implant applications.
Following are the types of the GPC Variable Angle Locking Two Column Volar Distal Radius Plates:
- Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 22 mm, 6 Head Holes (with option of ● Left and Right Variants)
- Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 25.5 mm, 7 Head Holes (with option of left and right variants)
- . Variable Angle Locking Two Column Volar Distal Radius Plate- Narrow, Width 19.5 mm, 6 Head Holes (with option of left and right variants)
Corresponding Screws for fixation:
- Variable Angle Locking Screw 2.4 mm, Star drive Lengths: 6mm to 30mm in 2mm increments
- FixLOCK Self-Tapping Screw 2.4 mm, Star drive Length 6mm to 30mm in 2mm increments
- Self-Tapping Cortex Screw 2.7 mm, Star drive Length: 12mm to 24mm
These implants are supplied non-sterile, the products have to be sterilized prior to use.
A5). Indications for Use:
GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is provided non-sterile.
GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. The system is indicated for use in adult patients only. All implants are for single use only.
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A6). Summary of Technological Characteristics as compared to the predicate devices:
A comparison between the GPC Variable Angle Locking Two Column Volar Distal Radius Plating System
and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.
Following is the summary of parameters in which the comparison has been verified:
| S. No. | Characteristics | Predicate Device Versus New Device (GPC Variable Angle Locking Two Column Volar Distal Radius Plates) | Remarks on Equivalence |
|---|---|---|---|
| 01 | Regulatory Classification | Same Classification and Regulation Number | Equivalent |
| 02 | Indications for use | Similar intended use in New Device and Predicate device | Equivalent |
| 03 | Material | Both the predicate and subject devices use material meant for surgical implant application | Equivalent |
| 04 | Performance Standards | Same performance standards used in both New Device as well as predicate device | Equivalent |
| 05 | Sterilization | Same method of sterilization used in both New Device as well as Predicate device | Equivalent |
| 06 | Dimensional Verification | Similar dimensions found in both New Device as well as Predicate device The minor differences that exist, do not raise any safety concerns. | Equivalent |
b1).Discussion on the non-clinical testing performed
The device performance of GPC Variable Angle Locking Two Column Volar Distal Radius Plating System has been demonstrated against following applicable standards
For GPC Variable Angle Locking Two Column Volar Distal Radius Plates:
- The testing performed as per ASTMF382 ●
Static Four Point Bend Test: Conforms Bending Fatique Properties: Conforms
For Bone Screws:
The Testing Performed As per ASTMF 543: Torsional Properties: Conforms,
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Driving Torque : Conforms, Pull-out Test: Conforms
b2). Discussion on the clinical evaluation referenced and relied up on:
GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is of similar design and pattern as well as similar intended use as that of predicate devices which are in market already and in clinical use. Therefore, Clinical information was not necessary to demonstrate substantial equivalence.
CONCLUSION:
From the available data we can justify that the GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is as safe, as effective and perform as same indications for use as that of already marketed predicate devices identified in a 3. of 510(k) summary.
Hence these devices can be considered safe and effective for their intended use.