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

Q: Who is the manufacturer of NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System?

Narang Medical Limited filed the 510(k) submission for NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System (K150561).

Q: What is the FDA product code for NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System?

HRS. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

Q: What is the regulatory pathway for NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System?

Synthes LCP Proximal Humerus Plate (K011815); 3.5 mm LCP Distal Humerus System (K033995); Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684); Synthes Clavicle Hook Plate (K061753); Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications (K082807); Synthes (USA) LCP Proximal Femur Plate and Screws (K030858); Synthes LCP Distal Femur Plates (K062564); Synthes LCP Proximal Tibia Plate (K011978/K023802); Synthes 4.5 mm LCP Straight Reconstruction Plates (K051986); Synthes Large Fragment Dynamic Compression Locking (DCL) System (K000682); Synthes Limited Contact-Dynamic Hip Screw Implant (LC-DHS) (K923613); Synthes Titanium Limited Contact-Dynamic Hip Screw Implant (Ti LC-DHS) (K953607); DYNAMIC CONDYLAR SCREW OR D.C.S (K840954); Synthes Cortical Screws (K112583).

Q: Who can help prepare an FDA 510(k) submission like NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K150561 · Narang Medical Limited · HRS · Nov 25, 2015 · Orthopedic

Device Facts

Record ID	K150561
Device Name	NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System
Applicant	Narang Medical Limited
Product Code	HRS · Orthopedic
Decision Date	Nov 25, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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

Device Story

System comprises metallic bone plates and screws for orthopedic trauma and reconstructive surgery. Plates feature various geometric configurations and screw holes for locking/non-locking screws; screws include cortex self-tapping and locking thread designs. DHS/DCS components include plates, lag screws, and compression screws for proximal femur fixation. Devices are used in clinical settings by surgeons for fracture fixation. Implants are provided non-sterile and require sterilization by the user. Output is mechanical stabilization of bone fractures. Benefits include restoration of skeletal alignment and support for bone healing.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing only, including mechanical performance verification (static/dynamic four-point bend tests for plates; torsional, insertion/removal torque, and axial pull-out tests for screws) per ASTM F382, F384, and F543.

Technological Characteristics

Materials: Ti-6Al-4V alloy (ASTM F136) or stainless steel (ASTM F138, F139). Components: Plates (straight/geometric) and screws (cortex/locking). DHS/DCS system includes lag, compression, and cortex screws. Sterilization: Non-sterile, user-sterilized via autoclaving (AAMI ST79, ISO 17665-1). Mechanical performance verified per ASTM F382, F384, F543.

Indications for Use

Indicated for adult patients requiring fixation of small and large bone fractures, arthrodesis, and osteotomy fixation, including clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibial pilon, fibula, pelvis, acetabulum, and periprosthetic fractures. DHS/DCS system indicated for proximal femur fractures (femoral neck, trochanteric, pertrochanteric, intertrochanteric). Locking systems suitable for osteopenic bone. Contraindicated for use in the spine.

Regulatory Classification

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.

Predicate Devices

Synthes LCP Proximal Humerus Plate (K011815)
3.5 mm LCP Distal Humerus System (K033995)
Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684)
Synthes Clavicle Hook Plate (K061753)
Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications (K082807)
Synthes (USA) LCP Proximal Femur Plate and Screws (K030858)
Synthes LCP Distal Femur Plates (K062564)
Synthes LCP Proximal Tibia Plate (K011978/K023802)
Synthes 4.5 mm LCP Straight Reconstruction Plates (K051986)
Synthes Large Fragment Dynamic Compression Locking (DCL) System (K000682)
Synthes Limited Contact-Dynamic Hip Screw Implant (LC-DHS) (K923613)
Synthes Titanium Limited Contact-Dynamic Hip Screw Implant (Ti LC-DHS) (K953607)
DYNAMIC CONDYLAR SCREW OR D.C.S (K840954)
Synthes Cortical Screws (K112583)

Related Devices

K153374 — CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System · Orthocare · Jun 17, 2016
K163425 — NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System · Narang Medical USA Corporation · Mar 24, 2017
K063020 — INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM · Intai Technology, Inc. · Dec 14, 2006
K191793 — Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System · Nebula Surgical Private Limited · Dec 9, 2019
K141680 — AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws · Auxein Medical · Jun 30, 2015

Submission Summary (Full Text)

{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 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 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 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, 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) | 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 | {4}------------------------------------------------ ### 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: ll #### Review Panel: Orthopaedic #### Regulation Number: 21 CFR 888.3030 and 21 CFR 888.3040 {5}------------------------------------------------ ## 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 Osteosynthesis Plating System | Locking | | 02 | Large Fragment Osteosynthesis Plating System | Locking | | 03 | DHS/DCS Plating System | NA | ## Further 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. {6}------------------------------------------------ ### 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 | Predicate Manufacturer's Name | Subject Device Name | |--------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------|-----------------------------------------------------------------------------------| | 1. | Synthes LCP Proximal Humerus Plate | K011815 | Synthes (USA) | Filos - Proximal Humerus Safety Lock Plate 3.5 - Standard | | 2. | 3.5 mm LCP Distal Humerus System | K033995 | Synthes (USA) | Distal Humerus Safety Lock Plate 2.7/3.5, Dorsolateral | | 3. | 3.5 mm LCP Distal Humerus System | K033995 | Synthes (USA) | Distal Humerus Safety Lock Plate 2.7/3.5, Dorsolateral with Lateral Support | | 4. | 3.5 mm LCP Distal Humerus System | K033995 | Synthes (USA) | Medial Distal Humerus Safety Lock Plate 2.7/3.5mm | | 5. | Synthes Small Fragment Dynamic Compression Locking (DCL) System | K000684 | Synthes (USA) | LC-DCP Safety Lock Plate 3.5 | | 6. | Synthes Small Fragment Dynamic Compression Locking (DCL) System | K000684 | Synthes (USA) | Safety Lock 'T' Plate 3.5, Right Angled | | 7. | Synthes Small Fragment Dynamic Compression Locking (DCL) System | K000684 | Synthes (USA) | Safety Lock 'T' Plate 3.5, Oblique Angled | | 8. | Synthes Clavicle Hook Plate | K061753 | Synthes (USA) | Clavicle Hook Safety Lock Plate 3.5 | | 9. | Synthes Small Fragment Dynamic Compression Locking (DCL) System | K000684 | Synthes (USA) | Reconstruction Safety Lock Plate 3.5 - Straight | | 10. | 3.5 mm LCP Distal Humerus System | (K033995) | Synthes (USA) | Safety Lock Screw Ø 2.7mm - Self Tapping | | | | | | | | 11. | Synthes Small Fragment Dynamic Compression Locking (DCL) System | K000684 | Synthes (USA) | Safety Lock Screw Ø 3.5mm - Self Tapping | | 12. | Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications | K082807 | Synthes (USA) | Broad LC-DCP Safety Lock Plate 4.5 /5.0 | | 13. | Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications | K082807 | Synthes (USA) | Narrow LC-DCP Safety Lock Plate 4.5/5.0 | | 14. | Synthes (USA) LCP Proximal Femur Plate and Screws | K030858 | Synthes (USA) | Proximal Femoral Safety Lock Plate 4.5/5.0/7.3 | | 15. | Synthes LCP Distal Femur Plates | K062564 | Synthes (USA) | Distal Femoral Safety Lock Plate 4.5/5.0 | | 16. | Synthes LCP Proximal Tibia Plate Synthes 4.5 mm Titanium LCP Proximal Tibia Plating System | For Stainless Steel Plate (K011978) For Titanium Plate K023802 | Synthes (USA) | Proximal Lateral Tibial Safety Lock Plate 4.5/5.0 | | 17. | Synthes Small Fragment Dynamic Compression Locking (DCL) System | K000684 | Synthes (USA) | Safety Lock 'T' Plate 4.5/5.0 | | 18. | Synthes Small Fragment Dynamic Compression Locking (DCL) System | K000684 | Synthes (USA) | L Buttress Safety Lock Plate 4.5/5.0 | | 19. | Synthes Small Fragment Dynamic Compression Locking (DCL) System | K000684 | Synthes (USA) | T Buttress Safety Lock Plate 4.5/5.0 | | 20. | Synthes 4.5 mm LCP Straight Reconstruction Plates | K051986 | Synthes (USA) | Reconstruction Safety Lock Plate 4.5/5.0 | | 21. | Synthes Large Fragment Dynamic Compression 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 Compression Plate (with Dynamic Compression Holes) | | | Synthes Titanium Limited Contact-Dynamic Hip Screw Implant (Ti LC-DHS)" for K953607 | K953607 | | | | | Synthes Limited Contact- Dynamic Hip Screw Implant (LC- DHS)" for K923613 | K 923613 | | Dynamic Hip Compression | | 23. | Synthes Titanium Limited Contact-Dynamic Hip Screw Implant (Ti LC-DHS)" for K953607 | K953607 | Synthes (USA) | Plate - Short Barrel (with Dynamic Compression Holes) | | 24. | DYNAMIC CONDYLAR SCREW OR D.C.S | K840954 | Synthes (USA) | DCS Plate 95° with Dynamic Compression Holes | | | Synthes Dynamic Hip Plate | K 923613 K953607 | Synthes (USA) | Standard Lag Screw, Ø 12.5mm | | 25. | Synthes Limited Contact- Dynamic Hip Screw Implant (LC- DHS)" for K923613 | K 923613 | | | | | Synthes Titanium Limited Contact-Dynamic Hip Screw Implant (Ti LC-DHS)" for K953607 | K953607 | Synthes (USA) | Compression Screw | | 26. | Synthes Cortical Screws | K112583 | Synthes (USA) | Cortex Screw Ø 3.5mm, Self Tapping | | 27. | Synthes Cortical Screws | K112583 | Synthes (USA) | Cortex Screw Ø 4.5mm, Self Tapping | {7}------------------------------------------------ {8}------------------------------------------------ ## 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: 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. {9}------------------------------------------------ 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 New Device (Auxein Brand) | Remarks | |--------|--------------------------|--------------------------------------------------------------------------------------|------------| | 01 | Indications for use | Similar intended use in New Device and Predicate device | Equivalent | | 02 | Material | Same material used in New Device and Predicate device | Equivalent | | 03 | Performance Standards | Same performance standards used in both New Device as well as predicate device | Equivalent | {10}------------------------------------------------ | 04 | Sterilization | Same method of sterilization used in both New Device as well as Predicate device | Equivalent | |----|-----------------------------|----------------------------------------------------------------------------------------|------------| | 05 | Dimensional Verification | Same dimensions found in both New Device 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 {11}------------------------------------------------ - 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 of Conclusion | Proposed Device | Predicate Device | |--------|----------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------| | 01 | Product Code | For Bone Plates: HRS For Bone Screws: HWC | Same | | 02 | Regulation Number | For Bone Plates: 21CFR 888.3030 For Bone Screws: 21CFR 888.3040 | Same | | 03 | Regulatory Class | Class II | Class II | | 04 | Indications For use | Same Indications For Use | Similar | | 05 | Sterilization | Provided Non-Sterile and to be sterilized using Autoclaving Method to achieve SAL of 10-6 AAMI ST79, ISO 17665-1 | Similar | {12}------------------------------------------------ | 06 | Mechanical Test Performance | 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 | Material Standards | 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.