NET Brand Small Fragment and Large Fragment Osteosynthesis System is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibial pilon, fibula, pelvis and acetabulum fractures; periprosthetic fractures; The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.

NET Brand DHS/DCS plating system may be used for fixation of the fractures of proximal femur such as femoral neck, trochanteric, pertrochanteric or intertrochanteric zones.

Device Description

NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System consists of plates and screws in a variety of designs and sizes and made from Ti-6Al-4V alloy or stainless steel. Plates are provided in straight designs and in various geometric configurations that are commonly used in trauma and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screws designs. Screws are provided in, 3.5mm Cortex Self-tapping, 4.5 mm Cortex self-tapping and 2.7mm self-tapping cortex locking, 3.5mm selftapping Cortex Locking, 5.0 mm cortex Locking thread designs in various lengths. This system is not indicated for use in spine.

NET Brand of DHS/DCS Plating System made from Ti-6Al-4V alloy or stainless steel and consist of DHS/DCS Plates, lag Screw, compression screw, and 4.5 Cortex screw Self Tapping, The DHS plates are available with barrel length 25mm (short barrel) and 38mm (Standard barrel) and barrel angels varies in 130° to 150°. The DCS plate is having angle of 95°

The DHS/DCS Screw is available in total length from 50 to 145 mm, thread length 22mm, shaft diameter 7 mm and outer diameter of 12.5. The thread of DHS/DCS Screw has a buttress type.

The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 36mm and outer diameter 4.0 mm.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the "NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System." This document aims to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria through a standalone study with acceptance criteria.

Therefore, the document does not contain the requested information about acceptance criteria and a study proving the device meets those criteria, as it is not a performance study in that sense.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This is achieved by comparing the new device's technological characteristics, intended use, materials, and performance (via testing against established ASTM standards) to those of already approved predicate devices.

Here's an explanation based on the provided text, addressing the points where information is available or noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not define specific "acceptance criteria" for clinical performance in terms of sensitivity, specificity, accuracy, or similar metrics for a new diagnostic or prognostic device. Instead, it demonstrates compliance with recognized engineering and material standards to show that the device performs equivalently to previously approved devices.

The "reported device performance" is essentially a confirmation of conformance to established ASTM standards for bone plates and screws.

Characteristic	Acceptance Criteria (Standard Compliance)	Reported Device Performance
Material	ASTM F 136, ASTM F 138, ASTM F 139	Conforms
Bone Plates (Static)	ASTM F 382, ASTM F 384 (Static Four Point Bend Test)	Conforms
Bone Plates (Dynamic)	ASTM F 382, ASTM F 384 (Dynamic Four Point Bend Test)	Conforms
Bone Screws (Torsional)	ASTM F 543 (Torsional Properties)	Conforms
Bone Screws (Driving)	ASTM F 543 (Driving Torque)	Conforms
Bone Screws (Pull-out)	ASTM F 543 (Pull-out Test)	Conforms

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

Sample Size: The document does not specify a "sample size" in terms of patient cases or images, as it is a mechanical device submission. The testing involves mechanical specimens (e.g., plates and screws) tested according to the cited ASTM standards. The specific number of specimens tested for each standard is not detailed in this summary.
Data Provenance: Not applicable as it's not a clinical or imaging study. The tests are mechanical and presumably conducted in a laboratory setting.

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

Not applicable. This is a submission for a bone fixation device, not a diagnostic device requiring expert interpretation for ground truth establishment. Mechanical testing relies on standardized methodologies, not expert consensus on clinical cases.

4. Adjudication method for the test set:

Not applicable for a mechanical device 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:

Not applicable. This is a medical device for bone fixation, not an AI or diagnostic tool.

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

Not applicable. This is a medical device for bone fixation, not an algorithm.

7. The type of ground truth used:

The "ground truth" in this context is the established performance benchmarks defined by recognized industry standards (ASTM F382, ASTM F384, ASTM F543 for performance, and ASTM F136, ASTM F138, ASTM F139 for materials). The device is deemed acceptable if it conforms to these standards, indicating mechanical properties are comparable to legally marketed devices.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not a machine learning model requiring a training set.

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

Not applicable, as there is no training set for this type of device submission. The "ground truth" for demonstrating substantial equivalence rests on adherence to material and performance standards, which are developed and accepted by the scientific and engineering community.

Summary

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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 encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a simple, flowing line.

November 25, 2015

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

Narang Medical Limited Mr. Vivek Narang Director 46, Naraina Industrial Area, Phase-1 New Delhi 110028 India

Re: K150561

Trade/Device Name: NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS 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: September 22, 2015 Received: September 29, 2015

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 or any Federal statutes and regulations administered by other Federal agencies. You must comply

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Page 2 - Mr. Vivek Narang

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 devicerelated 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 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/ResourcesforYou/Industry/default.htm. 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 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 yours,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K150561

Device Name

NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System

Indications for Use (Describe)

NET Brand DHS/DCS plating system may be used for fixation of the fractures of proximal femur such as femoral neck, trochanteric, pertrochanteric or intertrochanteric zones, 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:

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Premarket Notification 510(k) Summary As required by Section 807.92 General Company Information as required by 807:92 (a) (a.1)

Submitter's Name	:	Narang Medical Limited
Address
Office	:	46, Community Center, Naraina Industria Area,Phase-1, New Delhi 110028
Factory	:	Plot Number D-4, Sector A-2, Tronica City, Loni,Ghaziabad, 201102
CONTACT PERSON NAME	:	Mr. Vivek Narang
TITLE	:	Director
PHONE NUMBER	:	+91-45554000
Dated	:	18-11-2015

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This is a bundled submission.

Throughout the submission there is a mention of NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System that represents the range of products covered under this 510(k) submission.

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:

NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System,

NET Brand of DHS/DCS 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:

Review Panel:

Orthopaedic

Regulation Number:

21 CFR 888.3030 and 21 CFR 888.3040

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Variants/Types:

NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System are further subdivided into following categories

S. No.	Category	Types
01	Small Fragment OsteosynthesisPlating System	Locking
02	Large Fragment OsteosynthesisPlating System	Locking
03	DHS/DCS Plating System	NA

Further Description:

The DHS/DCS Screw is available in total length from 50 to 145 mm, thread length 22mm, shaft diameter 7 mm and outer diameter of 12.5. The thread of DHS/DCS Screw has a buttress type.

The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 36mm and outer diameter 4.0 mm.

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a3) IDENTIFICATION OF THE PREDICATE DEVICE:

For the purposes of US FDA's regulation of medical devices, NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System are substantially equivalent in indications and design principles to the following predicate devices.

S. No.	Device Name	510(k)Number	PredicateManufacturer'sName	Subject Device Name
1.	Synthes LCP ProximalHumerus Plate	K011815	Synthes (USA)	Filos - Proximal HumerusSafety Lock Plate 3.5 -Standard
2.	3.5 mm LCP Distal HumerusSystem	K033995	Synthes (USA)	Distal Humerus Safety LockPlate 2.7/3.5, Dorsolateral
3.	3.5 mm LCP Distal HumerusSystem	K033995	Synthes (USA)	Distal Humerus Safety LockPlate 2.7/3.5, Dorsolateralwith Lateral Support
4.	3.5 mm LCP Distal HumerusSystem	K033995	Synthes (USA)	Medial Distal Humerus SafetyLock Plate 2.7/3.5mm
5.	Synthes Small Fragment DynamicCompression Locking (DCL)System	K000684	Synthes (USA)	LC-DCP Safety Lock Plate 3.5
6.	Synthes Small FragmentDynamic CompressionLocking (DCL) System	K000684	Synthes (USA)	Safety Lock 'T' Plate 3.5,Right Angled
7.	Synthes Small FragmentDynamic CompressionLocking (DCL) System	K000684	Synthes (USA)	Safety Lock 'T' Plate 3.5,Oblique Angled
8.	Synthes Clavicle Hook Plate	K061753	Synthes (USA)	Clavicle Hook Safety LockPlate 3.5
9.	Synthes Small Fragment DynamicCompression Locking (DCL)System	K000684	Synthes (USA)	Reconstruction Safety LockPlate 3.5 - Straight
10.	3.5 mm LCP Distal HumerusSystem	(K033995)	Synthes (USA)	Safety Lock Screw Ø 2.7mm -Self Tapping

11.	Synthes Small FragmentDynamic CompressionLocking (DCL) System	K000684	Synthes (USA)	Safety Lock Screw Ø 3.5mm -Self Tapping
12.	Synthes (USA) 3.5 mm and 4.5mm Locking Compression Plate(LCP) System with ExpandedIndications	K082807	Synthes (USA)	Broad LC-DCP Safety LockPlate 4.5 /5.0
13.	Synthes (USA) 3.5 mm and 4.5mm Locking Compression Plate(LCP) System with ExpandedIndications	K082807	Synthes (USA)	Narrow LC-DCP Safety LockPlate 4.5/5.0
14.	Synthes (USA) LCP ProximalFemur Plate and Screws	K030858	Synthes (USA)	Proximal Femoral Safety LockPlate 4.5/5.0/7.3
15.	Synthes LCP Distal Femur Plates	K062564	Synthes (USA)	Distal Femoral Safety LockPlate 4.5/5.0
16.	Synthes LCP Proximal Tibia PlateSynthes 4.5 mm Titanium LCPProximal Tibia Plating System	For StainlessSteel Plate(K011978)ForTitaniumPlateK023802	Synthes (USA)	Proximal Lateral Tibial SafetyLock Plate 4.5/5.0
17.	Synthes Small FragmentDynamic CompressionLocking (DCL) System	K000684	Synthes (USA)	Safety Lock 'T' Plate 4.5/5.0
18.	Synthes Small FragmentDynamic CompressionLocking (DCL) System	K000684	Synthes (USA)	L Buttress Safety Lock Plate4.5/5.0
19.	Synthes Small FragmentDynamic CompressionLocking (DCL) System	K000684	Synthes (USA)	T Buttress Safety Lock Plate4.5/5.0
20.	Synthes 4.5 mm LCPStraight ReconstructionPlates	K051986	Synthes (USA)	Reconstruction Safety LockPlate 4.5/5.0
21.	Synthes Large Fragment DynamicCompression Locking (DCL)System	K000682	Synthes (USA)	Safety Lock Screw Ø 5.0mm

22.	Synthes Limited Contact-Dynamic Hip Screw Implant (LC-DHS)" for K923613	K 923613	Synthes (USA)	Dynamic Hip CompressionPlate (with DynamicCompression Holes)
	Synthes Titanium LimitedContact-Dynamic Hip ScrewImplant (Ti LC-DHS)" forK953607	K953607
	Synthes Limited Contact-Dynamic Hip Screw Implant (LC-DHS)" for K923613	K 923613		Dynamic Hip Compression
23.	Synthes Titanium LimitedContact-Dynamic Hip ScrewImplant (Ti LC-DHS)" forK953607	K953607	Synthes (USA)	Plate - Short Barrel (withDynamic Compression Holes)
24.	DYNAMIC CONDYLARSCREW OR D.C.S	K840954	Synthes (USA)	DCS Plate 95° with DynamicCompression Holes
	Synthes Dynamic Hip Plate	K 923613K953607	Synthes (USA)	Standard Lag Screw, Ø12.5mm
25.	Synthes Limited Contact-Dynamic Hip Screw Implant (LC-DHS)" for K923613	K 923613
	Synthes Titanium LimitedContact-Dynamic Hip ScrewImplant (Ti LC-DHS)" forK953607	K953607	Synthes (USA)	Compression Screw
26.	Synthes Cortical Screws	K112583	Synthes (USA)	Cortex Screw Ø 3.5mm, SelfTapping
27.	Synthes Cortical Screws	K112583	Synthes (USA)	Cortex Screw Ø 4.5mm, SelfTapping

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

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

Indications for Use:

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NET Brand DHS/DCS plating system may be used for fixation of the fractures of proximal femur such as femoral neck, trochanteric, pertrochanteric or intertrochanteric zones.

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

The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject and predicate devices are all fabricated from the same or similar materials and share similar design characteristics.

The subject and predicate devices encompass the same range of physical dimensions, are packaged using the same materials, and are to be sterilized by the same methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy. Performance data provided to demonstrate substantial equivalence included engineering analysis and mechanical testing according to ASIM F382, ASTM F 384 and ASTM F543.

Overall, Small Fragment and Large Fragment Osteosynthesis System of Narang Medical Limited have the following similarities to the predicate devices:

- has the same intended use,
- uses the same operating principle,
- incorporates the same basic design,
- incorporates the same or very similar materials, and

has similar packaging and can be sterilized using the same materials and processes.

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

S. No.	Characteristics	Predicate Device Versus NewDevice (Auxein Brand)	Remarks
01	Indications for use	Similar intended use in New Deviceand Predicate device	Equivalent
02	Material	Same material used in New Deviceand Predicate device	Equivalent
03	PerformanceStandards	Same performance standards used inboth New Device as well as predicatedevice	Equivalent

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04	Sterilization	Same method of sterilization used inboth New Device as well asPredicate device	Equivalent
05	DimensionalVerification	Same dimensions found in both NewDevice as well as Predicate device	Equivalent

b1). Discussion on the non-clinical testing performed

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

A: Material Standards
B: Performance Standards

A: Material Standards: The raw material standards are the first standards to be complied, as it ensures compliance to the materials to be used for manufacturing of metallic surgical implants.

following material standards have been adopted and complied:

ASTM F 136: Standard specification for wrought Titanium-6Aluminium-1. 4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.

ட Standard Specification for Wrought 2. ASTM 138: 18 chromium-14Nickel-2.5Molybdenum stainless steel bar and wire for surgical implants.

ட 3. ASTM 139: Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants

B: Performance Standards:

The performance of NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System has been verified as per the following standards

ASTM F 382,
ASTM F 384 and
ASTM F 543
For Bone Plates:

As per ASTM F 382 and ASTM F 384 Static Four Point Bend Test: Conforms, Dynamic Four Point Bend Test: Conforms

For Bone . Screws:
SECTION 05

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As per ASTM F 543 :Torsional Properties: Conforms, Driving Torque : . Conforms, Pull-out Test: Conforms

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

NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System,

NET Brand of DHS/DCS Plating System are of similar design and pattern as well as similar indications for use. Therefore Clinical information was not necessary to demonstrate substantial equivalence.

CONCLUSION:

General, Safety and Performance conclusion:

S. No.	Parameter ofConclusion	Proposed Device	PredicateDevice
01	Product Code	For Bone Plates: HRSFor Bone Screws: HWC	Same
02	RegulationNumber	For Bone Plates: 21CFR 888.3030For Bone Screws: 21CFR 888.3040	Same
03	Regulatory Class	Class II	Class II
04	Indications Foruse	Same Indications For Use	Similar
05	Sterilization	Provided Non-Sterile and to be sterilized usingAutoclaving Method to achieve SAL of 10-6 AAMIST79, ISO 17665-1	Similar

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06	Mechanical TestPerformance	For Bone Plates:	Same
		As per ASTM F 382 and ASTM F 384
		- Static Four Point Bend Test Conforms
		- Dynamic Four Point Bend Test Conforms
		For Bone Screws:
		As per ASTM F 543
		- Torsional Properties Conforms
		- Insertion Torque Conforms
		- Removal Torque Conforms
		- Axial Pull-out Test Conforms
07	MaterialStandards	ASTM F 136, ASTM F 138 and ASTM F 139	Same

General, Safety and Performance Conclusion:

From the available data available we can justify that the NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS 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.

Therefore, our 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.