GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. by GPC MEDICAL LTD

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).

The system is indicated for use in adult patients only. All implants are for single use only.

Device Description

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws.

The plates and screws are fabricated from Stainless Steel and Titanium.

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available: like, Reconstruction Plates, T-Plates, Anatomical Plates and Clavicle Hook Plates.

These all are mainly divided into

Large Fragment Plates
. Small Fragment Plates
Mini Fragment Plates ●

The number of the holes varies from 2 to 22.

The Locking screw implants are in corresponding diameter ranges from 2.4mm, 3.5mm, 5.0mm and 6.5mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 150mm

The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm. The non locking screws 3.5mm and 4.5mm were cleared previously in 510k number K092493

These implants are supplied non-sterile, the products have to be sterilized prior to use.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically orthopaedic bone plates and screws. For such submissions, the FDA typically evaluates substantial equivalence to legally marketed predicate devices, rather than requiring extensive clinical trials to demonstrate new performance metrics and acceptance criteria in the same way one might for a novel drug or a high-risk, de novo medical device.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a new drug or novel medical device (e.g., sample size for test set, data provenance, expert adudication, MRMC studies, standalone performance, training set details) is not directly applicable or present in this type of 510(k) submission for a Class II orthopedic implant.

Instead, the "acceptance criteria" here are based on demonstrating that the new device is substantially equivalent to existing cleared devices in terms of:

Indications for Use: The new device is intended for the same purpose as the predicate devices.
Technological Characteristics: The new device has similar design, materials, and operating principles.
Performance: The new device performs similarly to the predicate devices, often demonstrated through engineering analysis, material testing, and comparison of specifications rather than large-scale clinical outcome studies.

Let's address the points as best as possible given the provided document's context:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the "acceptance criteria" are primarily established by the performance and characteristics of the predicate devices. The "study" proving acceptance is the demonstration of substantial equivalence through comparison and testing against relevant standards.

Acceptance Criteria (based on Predicate Equivalence & Standards)	Reported Device Performance (as stated in submission)
Material Standards Compliance: - ASTM F 136 (Titanium-6Aluminium-4Vanadium ELI) - ASTM F 138 (18Cr-14Ni-2.5Mo stainless steel bar/wire) - ASTM F 139 (18Cr-14Ni-2.5Mo stainless steel sheet/strip)	"We have complied to following material standards" "verified the purchased material compliance to these standards and copies of the relevant test results were provided in the submission."
Plate Performance (Bending): - Engineering analysis of bending moment and bending stiffness as per predicate performance/industry standards.	"The performance of the plates was demonstrated using an engineering analysis of bending moment and bending stiffness based on material properties and the plate shaft dimensions."
Screw Performance (Pull-out Strength & Torque-to-Failure): - Engineering analysis of pull-out strength and torque-to-failure as per predicate performance/industry standards.	"The performance of the screws was demonstrated using an engineering analysis of pull-out strength and torque-to-failure based on material properties and the screw dimensions."
Indications for Use Equivalence: - Treat fractures of clavicle, scapula, long bones (humerus, ulna, radius, femur, tibia, fibula), and small bones (metacarpals, metatarsals, phalanges) in adults. Single use.	"Similar intended use in New Device and Predicate device" "GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis (note: pelvis included here but not in the original IU), scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges). The system is indicated for use in adult patients only. All implants are for single use only."
Material Equivalence: - Stainless Steel and Titanium.	"Same material used in New Device and Predicate device" "The plates and screws are fabricated from Stainless Steel and Titanium."
Performance Standards Equivalence: - (Implicitly, adherence to recognized orthopedic implant performance standards, e.g., for fatigue, corrosion, biomechanics, if applicable to the device type and specified by the predicate)	"Same performance standards used in both New Device as well as predicate device" (This suggests the device was tested against or designed to meet the same relevant standards as the predicates, beyond just material standards).
Sterilization Method Equivalence: - Must be consistent with the predicates for "non-sterile" and subsequent required sterilization prior to use (e.g., autoclave).	"Same method of sterilization used in both New Device as well as Predicate device" "These implants are supplied non-sterile, the products have to be sterilized prior to use."
Dimensional Verification Equivalence: - Dimensions (e.g., hole count, screw diameters, lengths) must be comparable to predicates.	"Same dimensions found in both New Device as well as Predicate device" "The number of the holes varies from 2 to 22. The Locking screw implants are in corresponding diameter ranges from 2.4mm, 3.5mm, 5.0mm and 6.5mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 150mm. The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm."

Based on the provided document, the following points are not applicable or not detailed, as this is a 510(k) for a device demonstrated through substantial equivalence and engineering analysis, not a clinical study of diagnostic performance or human-in-the-loop AI assistance:

MRMC comparative effectiveness study: Not done/not applicable for this type of device submission.
Standalone (algorithm only) performance: Not applicable.
Ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of engineering and material equivalence submission. The "ground truth" here is compliance with established material and performance standards, and similarity to predicate devices.
Sample size for the training set: Not applicable (no AI/machine learning model).
How the ground truth for the training set was established: Not applicable.

Regarding the other specific requested information:

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical data for performance evaluation. For material and mechanical testing, the "sample size" would refer to the number of components tested according to the relevant ASTM standards or internal protocols. This level of detail on the number of physical samples tested is typically in the underlying test reports, not summarized in the 510(k) summary provided.
Data Provenance: The device manufacturer (GPC Medical Limited) is located in India. The "testing" involved non-clinical (material and engineering) analyses. The data provenance would be from the manufacturer's internal testing or accredited test labs. The submission explicitly states "copies of the relevant test results were provided in the submission" for material compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in the context of this 510(k). "Ground truth" here is about compliance with engineering and material standards, which are established by consensus standard organizations (e.g., ASTM) and verified by qualified engineers/technicians in labs. It does not involve expert clinical readers establishing a "ground truth" for a diagnostic task.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There's no clinical adjudication process for this type of submission.

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, this was not done. This device is a bone plate and screw system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this was not done.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's acceptance is based on:
- Material Standards: Adherence to established ASTM material specifications for surgical implants.
- Engineering Performance Standards: Meeting performance characteristics (e.g., bending moment, stiffness, pull-out strength, torque-to-failure) demonstrated through engineering analysis and potentially mechanical testing, comparable to the predicate devices and industry norms.
- Predicate Device Equivalence: The characteristics and intended use being substantially similar to already legally marketed devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, representing the department's focus on health and human well-being. The profiles are depicted in a simple, abstract manner.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 17, 2016

GPC Medical Limited Mr. Vikas Narang Director-Exports M-Block, DDA LSC, Vikas Puri New Delhi, 110018 INDIA

Re: K153716 Trade/Device Name: GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System 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: April 8, 2016 Received: April 11, 2016

Dear Mr. 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. 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

{1}------------------------------------------------

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 Parts 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 (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K153716

Device Name

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.

Indications for Use (Describe)

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavic, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).

The system is indicated for use in adult patients only. All implants are for single use only.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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}------------------------------------------------

Premarket Notification 510(k) Summary as required by Section 807.92

General Company Information as required by 807:92 (a)

(a.1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared

Submitter's Name:

GPC Medical Ltd.

Address:

Office:

M Block, DDA LSC, Vikas Puri, New Delhi 110018 India

Factory: A-82, Sector A-4, Tronica City, Loni, Ghaziabad, Uttar Pradesh 201102

Contact Person Name:	Mr. Vikas Narang
Title:	Director-Exports
Phone Number:	+91-9810638797
Dated:	21-12-2015

This is a bundled submission.

Throughout the submission there is a mention of GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System that represents the range of products covered under this 510(k) submission.

{4}------------------------------------------------

a.2: The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known

Proprietary Name:

. GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
Common or Usual Name:
Orthopaedic Bone Plates
Orthopaedic Bone Screws

Classification Name:

PLATES, FIXATION, BONE
· SCREWS, FIXATION, BONE

Product Code:	HRS, HWC
Device Class:	II
Review Pane:	Orthopaedic
Regulation Number:	21 CFR 888.3030 and 21 CFR 888.3040
Variants/Types:	GPC BRAND Locking Bone Plates and Screws OsteosynthesisPlating System are further subdivided into following categories

S. No.	Category	Types
01	Large Fragment Plates	Locking Version
02	Small Fragment Plates	Locking Version
03	Mini Fragment Plates	Locking Version
04	Bone Screws	Locking and Non-LockingVersion

{5}------------------------------------------------

Further Description of GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.

Generally there are following types of bone plates used with cortical (cortex) and Locking Screws. These bone plates are generally designed on the basis of the boñe contour and anatomy.

S. No.	Type	Subtype
01	Small and LargeFragment	T-Shaped, Hook Angled Plates. Reconstructions plates
02	Dynamic compression	Small DCP, Narrow DCP, Lengthening Narrow, BroadDCP, Lengthening Broad Plates
03	Mini Fragment	T-Shaped

{6}------------------------------------------------

A3) Identification of the Predicate Device:

Following are the predicate device 510(k) with which we are declaring substantial equivalence:

Following is the range of variants covered with their corresponding predicate devices.

S. No.	Subject Device	Predicate Device
01	4.5mm Narrow Locking Plate	Synthes 3.5 and 4.5mm LockingCompression Plate System (K082807)
02	4.5mm Broad Locking Plate	Synthes 3.5 and 4.5mm LockingCompression Plate System (K082807)
03	4.5mm/5.0mm Broad Curved Locking Plate	Synthes 3.5 mm and 4.5 mmCurved Narrow and Broad LockingCompression Plates (K082807)
04	4.5mm Reconstruction Locking Plate	Synthes 4.5 mm LCP StraightReconstruction Plate (K051986)
05	Proximal Femur Locking Plate	Synthes (USA) LCP Proximal FemurPlate (K030858)
06	Locking Lateral Proximal Tibia Plate, Leftand Right	Synthes LCP Proximal TibiaPlate (K023802, K030597, K983787)
07	4.5mm Distal Femur Locking Plate, Left andRight	Synthes LCP Distal FemurPlates (K062564)
08	Locking T-Plate 3.5mm, Oblique Angled, Leftand Right	Synthes Small Fragment DynamicCompression Locking( DCL) System(K000684)
09	Small Dynamic Compression Plate 3.5mm withLC Under Cuts	Synthes 3.5 (USA) LockingCompression Plate System (K082807)
10	3.5mm Small 'T' Plate – 3 Head Holes	Synthes Small Fragment DynamicCompression Locking( DCL)System(K000684)
11	3.5mm Small 'T' Plate – 4 Head Holes	Synthes Small Fragment DynamicCompression Locking(DCL)System(K000684)
12	Proximal Tibia Locking Plate, Left and Right	Synthes 3.5mm Titanium LCPProximal Tibia Plate (K030597) ORSynthes LCP Proximal Tibia Plates(K011978)
13	Locking Anterolateral Tibia Distal Plate 3.5mm	Synthes (USA) LCP AnterolateralDistal Tibia Plate 3.5 (K092812)
14	Locking Clavicle Hook Plate 3.5mm, Left and Right	Synthes Clavicle Hook Plate(K061753)
15	3.5mm Proximal Humerus Locking Plate	Proximal humerus plate longSynthes K041860 K062494 EBI Optilock UpperExtremity Plating System
16	Distal Humerus Locking Plate, Size 2.7/3.5mm,Left and Right	Synthes 3.5mm LCP DistalHumerus System (K033995)
17	Distal Humerus Locking Plate, 2.7/3.5mm withLateral Support, Left and Right	Synthes 3.5mm LCP DistalHumerus System (K033995)
18	Locking Medial Distal Tibia Plate without Tab,Left and Right	Synthes Medial Distal Tibia Plate(K001945)
19	Locking Philous Plate	Synthes (USA) LCP® ProximalHumerus Plates, Long (K041860)
20	'T' Distal Radius 2.4mm Locking Plate	K982732 or K012114 (Synthes lockingdistal radius plating system)
21	Locking Distal Radius Buttress Plate 2.4mm	Synthes (USA) LCP Radial Head PlatingSystem (K040777)
22	Self Tapping Locking Screw 2.4mm	Synthes 2.4mm Titanium lockingscrew (K033975)K051567 APTUS Titanium FixationSystem
23	Self Tapping Locking Screw 2.7mm	Synthes Small Fragment DynamicCompression Locking (DCL) System(K000684)K051567 APTUS Titanium FixationSystem
24	Self Tapping Locking Screw 3.5mm	Synthes Small Fragment DynamicCompression Locking (DCL) System(K000684)K051567 APTUS Titanium FixationSystem
25	Self Tapping Locking Screw 5.0mm	Synthes Large Fragment DynamicCompression Locking (DCL) System(K000682)K051567 APTUS Titanium FixationSystem
26	6.5mm Self Tapping Locking CannulatedScrew	Synthes Cannulated Screw SystemK021932 K051567 APTUS Titanium FixationSystem

{7}------------------------------------------------

{8}------------------------------------------------

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

Device Description:

The plates and screws are fabricated from Stainless Steel and Titanium.

These all are mainly divided into

Large Fragment Plates
. Small Fragment Plates
Mini Fragment Plates ●

The number of the holes varies from 2 to 22.

The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm. The non locking screws 3.5mm and 4.5mm were cleared previously in 510k

Rev: 02 SECTION 5 Date: 27.04.2016 PAGE 6 OF 10

{9}------------------------------------------------

number K092493

These implants are supplied non-sterile, the products have to be sterilized prior to use.

{10}------------------------------------------------

A5). (5) A statement of the intended use of the device

Indications for Use:

· GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are provided nonsterile.

The system is indicated for use in adult patients only. All implants are for single use only.

a6). Summary of Technological Characteristics as compared to the predicate devices:

Substantial equivalence including comparison with predicate devices

A comparison between the GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.

S. No.	Characteristics	Predicate Device Versus NewDevice (GPC Brand)	Remarks
01	Indications for use	Similar intended use in New Deviceand Predicate device	Equivalent
02	Material	Same material used in New Device andPredicate device	Equivalent
03	PerformanceStandards	Same performance standards used in bothNew Device as well as predicate device	Equivalent
04	Sterilization	Same method of sterilization used inboth New Device as well as Predicatedevice	Equivalent
05	DimensionalVerification	Same dimensions found in both NewDevice as well as Predicate device	Equivalent

Following is the summary of parameters in which the comparison has been verified:

{11}------------------------------------------------

b1). Discussion on the non-clinical testing performed

Following are the applicable product standards considered for non-clinical standards

Material A: Standards

B: Performance Standards

Material A: Standards:

The material standards are the essential part to be complied to first, as it is the basis of manufacturing metallic surgical implants.

We have complied to following material standards

1. ASTM F 136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
1. ASTM F 138: Standard Specification for Wrought 18 chromium-14Nickel-2.5Molybdenum stainless steel bar and wire for surgical implants.
1. ASTM F 139: Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants

We have verified the purchased material compliance to these standards and copies of the relevant test results were provided in the submission.

The performance of the plates was demonstrated using an engineering analysis of bending moment and bending stiffness based on material properties and the plate shaft dimensions.

The performance of the screws was demonstrated using an engineering analysis of pull-out strength and torque-to-failure based on material properties and the screw dimensions.

{12}------------------------------------------------

b2). Discussion on the clinical evaluation referenced and relied upon:

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are of similar design and pattern as well as similar intended use. Clinical information was not necessary to demonstrate substantial equivalence.

CONCLUSION:

General, Safety and Performance conclusion:

From the available data available we can justify that the GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are as safe, as effective and perform as same indications for use as that of already marketed predicate devices identified in a3. of 510(k) summary.

Hence these devices can be considered safe and effective for their intended use.

Regulation Number and Section

§ 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.