GPC Intramedullary Nailing Systems

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, representing the department's focus on people and health. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 30, 2015 GPC Medical Limited Vikas Narang Director-Exports Plot Number 8, Shubh Plaza M-Block DDA LSC, Vikas Puri New Delhi, 110018 INDIA Re: K143245 Trade/Device Name: GPC Intramedullary Nailing Systems Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB. JDS Dated: July 30, 2015 Received: August 4, 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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/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 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}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K143245 Device Name GPC Intramedullary Nailing System #### Indications for Use (Describe) 1. Indication for Use: Multi Angle Tibial Nail is intended to stabilize fracture of the proximal & distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre and post isthmic fractures and tibial malunions & nonunions. 2. Indications for Use: Ga-mma Nail is indicated for use in stabilizing various types of intertrochanteric fractures of proximal femur. 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows a logo with the letters GPC in white, set against a blue background. The letters are bold and sans-serif. The blue background is in the shape of a rounded hexagon, with a thick blue border. The logo appears to be for an organization or company with the initials GPC. Image /page/3/Picture/2 description: The image shows the logo for GPC Medical Ltd. The logo is in green and has the text "GPC Medical Ltd." in a sans-serif font. Below the company name is the text "Govt. of India Recognized Star Export House" in a smaller, black font. The logo is simple and professional. Image /page/3/Picture/3 description: The image shows a logo or emblem with several certifications and claims. The text "The Best Name in India in its field" is prominently displayed at the top. Below this, it states "Backed by experience since 1930." The image also includes a "CE" mark, along with certifications such as "ISO 9001:2008 Certified," "ISO 13485:2003 Certified," "WHO-GMP Compliant," and "US FDA 510 (k)." # 510(k) Summary of Safety and Effectiveness (A.1) General Company Information | GPC Medical Limited<br>Plot Number 8, Shubh Plaza, M Block, DDA LSC, Vikas Puri,<br>New Delhi 110018, India | | | |-------------------------------------------------------------------------------------------------------------|--|--| | Mr. Vikas Narang | | | | +91-11-4322600 (100 Lines) | | | | 27-10-2014 | | | | GPC Intramedullary Nailing Systems | | | | HSB – Primary Code<br>JDS - Secondary Code | | | | Class II | | | | 21CFR 888.3020 Intramedullary Fixation Rod | | | | GPC Intramedullary Nailing Systems | | | | Common or Usual Name:<br>Intramedullary Nail | | | | Nail, Fixation, Bone | | | | | | | Models: | S. No. | Specific Device Model Type | |--------|----------------------------| | 01 | Multi Angle Tibial Nail | | 02 | Ga-mma Nail | PAGE 1 OF 9 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the logo for GPC Medical Ltd. The logo includes the company's name in green text, along with the tagline "Govt. of India Recognized Star Export House." There is also a red text that says "The Best Name in India in its field." The logo also mentions ISO 9001:2008 and ISO 13485:2003 certifications. Further for the fixation of GPC intramedullary nailing systems, there are locking bolts, and end caps that are used during surgical procedure for fixation of these devices in the fractured bones. Following are the corresponding locking bolts and end caps. Locking Bolts for Multi Angle Tibial Nail End Cap for Multi Angle Tibial Nail Lag Screw for Ga-mma Nail Locking Screw for Ga-mma Nail Set Screw for Ga-mma Nail End Cap for Ga-mma Nail ### Available Sizes: Multi Angle Tibial Nail: 260mm to 360mm with 20mm interval between adjacent sizes. Ga-mma Nail: single size of 180mm SECTION 05 {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for GPC, which is in a blue color. The letters "GPC" are in a bold, sans-serif font. The logo is enclosed in a blue, rounded hexagon shape with a white outline. The logo is simple and clean, and the blue color gives it a professional look. Image /page/5/Picture/2 description: The image shows the logo for IPC Medical Ltd. The logo is in green and has the company name in a large font. Below the company name, in a smaller font, it says "Govt. of India Recognized Star Export House." Image /page/5/Picture/3 description: The image contains a logo with the text "The Best Name in India in its field" in red font. Below the text, it says "Backed by experience since 1930". To the left is the CE marking symbol. To the right are certifications including ISO 9001:2008 Certified, ISO 13485:2003 Certified, WHO-GMP Compliant, and US FDA 510 (k). # A 3) IDENTIFICATION OF THE PREDICATE DEVICE: Following are the predicate device 510(k) with which we are declaring substantial equivalence: | S. No. | Name of Device | Manufacturer (Predicate Device | 510(k) number | GPC Name | Device | Remarks | |--------|-----------------------|--------------------------------|---------------|----------------|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 01 | Tibial Nail System Ex | Synthes (USA) | K040762 | GPC Angle Nail | Multi Tibial | | | 02 | Gamma Nail | Howmedica Inc. | K972813 | GPC Nail | Ga-mma | The Howmedica Inc.'s Gamma Locking Nail is now available as Stryker's Gamma Locking Nail, however the 510(k) is still available in US FDA database as that of Howmedica Inc. | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for GPC Medical Ltd. The logo includes the text "GPC Medical Ltd." in green font, with the tagline "Govt. of India Recognized Star Export House" underneath. To the left of the text is a blue hexagon with the letters "GPC" inside. To the right of the text is the phrase "The Best Name in India in its field" in red font, along with the CE marking and ISO certifications. A 4). Device Description: GPC Intramedullary Nailing Systems: The GPC Intramedullary Nailing Systems include intramedullary nails and corresponding screws/end caps/locking bolts for fastening these intramedullary nails to the fractured bones. A 5) Indications for Use: ### 1. Indication for Use: Multi Angle Tibial Nail The Multi Angle Tibial Nail is intended to stabilize fracture of the proximal & distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre and post isthmic fractures and tibial malunions & nonunions - 2. Indications for Use: Ga-mma Nails The Ga-mma Nail is indicated for use in stabilizing various types of intertrochanteric fractures of proximal femur. - 1. Associated materials of construction: NIL - Identification of colour additives present (if any): NIL 2. - 3. Contact classification of the devices as per ISO 10993-1:2009 standard: Surgically Invasive, Long-Term, Implantable Devices in connection with tissue and bone. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image contains the logo for GPC Medical Ltd. The logo includes the text "GPC Medical Ltd." in green font, with the tagline "Govt. of India Recognized Star Export House" underneath. To the left of the text is a blue hexagon with the letters "GPC" inside. To the right of the text is the phrase "The Best Name" in red cursive font, along with the text "Backed by expe ISO 9001: ISO 13485". A 6). Summary of Technological Characteristics as compared to the predicate device SUBSTANTIAL EQUIVALENCE INCLUDING COMPARISON WITH PREDICATE DEVICES A comparison between GPC Intramedullary Nailing Systems and predicate devices has been performed which has resulted in demonstration of equivalence in dimensional and performance criteria. Despite some dimensional variation, the equivalence has been demonstrated by performance bench testing of both subject and predicate devices. ### Following is the summary of parameters in which the comparison has been verified: Multi Angle Tibial Nail versus Predicate Device | S. No. | CHARACTERISTICS | PREDICATE DEVICE<br>VERSUS NEW DEVICE<br>(GPC Intramedullary Nailing<br>Systems) | REMARKS | |--------|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | 01 | Indications for use | Same intended use in New Device and Predicate device | Equivalent | | 02 | Material | Same material used in New Device and Predicate device, however, Subject device is available in Stainless Steel type also. | Equivalent | | 03 | Performance Standards | Same performance standards used in both New Device as well as predicate device | Equivalent | | 04 | Sterilization | Same method of sterilization used in both New Device as well as Predicate device | Equivalent | | 05 | Dimensional Verification | There are two differences in the geometry however, these do not affect the safety and do not raise any safety concerns over the predicate device. A detailed analysis is provided in Section-10 Executive summary. The performance test results however are at part indicating the performance equivalence | Equivalent | SECTION 05 PAGE 5 OF 9 {8}------------------------------------------------ IPC Medical Ltd. Govt. of India Recognized Star Export House Image /page/8/Picture/3 description: The image contains a logo with the text "The Best Name in India" in a stylized red font. Below that, it says "in its field" in a smaller, black font. Underneath that, it says "Backed by experience since 1930" also in a smaller, black font. € ISO 9001:2008 Certified ISO 13485:2003 Certified WHO-GMP Compliant US FDA 510 (k) ## Following is the summary of parameters in which the comparison has been verif Ga-mma Nail versus Predicate Device | S. No. | CHARACTERISTICS | PREDICATE DEVICE<br>VERSUS NEW DEVICE<br>(GPC Intramedullary Nailing<br>Systems) | REMARKS | |--------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | 01 | Indications for use | Same 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 | | 04 | Sterilization | Same method of sterilization used in both New Device as well as Predicate device | Equivalent | | 05 | Dimensional Verification | The end cap in subject device has been provided with collar that prevents sharp edges at the proximal end of nail to avoid vascular trauma, and also giving additional strength and safety to the proximal end of the nail, however that does not lead to any safety concerns related to device performance. | Equivalent | {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for GPC Medical Ltd. The logo consists of the letters "GPC" inside of a blue hexagon on the left, and the words "GPC Medical Ltd." in green on the right. Below the company name is the text "Govt. of India Recognized Star Export House" in black. Image /page/9/Picture/2 description: The image shows a logo with several certifications and claims. The text "The Best Name in India in its field" is prominently displayed at the top. Below this, it states "Backed by experience since 1930." The logo also includes the certifications ISO 9001:2008, ISO 13485:2003, WHO-GMP Compliant, and US FDA 510 (k), indicating compliance with various quality and regulatory standards. ### B 1) 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 material standards are the essential part to be complied to first, as it is the basis of manufacturing metallic surgical implants. We have complied with two material standards - 1. ASTM F 136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications. - 2. ASTM F 138: Standard Specification for Wrought 18 chromium-14Nickel-2.5Molybdenum stainless steel bar and wire for surgical implants. ### B: Performance Standards: We have verified the product compliance to these standards-ASTM F 1264 for Multi Angle Tibial Nail and ASTM F 384 for Ga-mma Nails and the relevant test results comparing the subject devices with predicate devices is given in section-10 executive summary. B 2) Discussion on the clinical evaluation referenced and relied upon: GPC Intramedullary nailing systems are of similar design and pattern as well as similar indications for use, similar technological characteristics to that of predicate devices. Following is the flow chart that has been considered for clinical evaluation / clinical equivalence {10}------------------------------------------------ Image /page/10/Figure/1 description: The image is a flowchart titled "Figure 1: Stages of clinical evaluation". The flowchart shows the stages of clinical evaluation, starting with Stage 1, which involves identifying clinical data from literature searching, clinical experience, and clinical investigation. The flowchart then moves to Stage 2, which involves appraisal of individual data sets, suitability, and contribution of results to demonstration of performance and safety, and then to Stage 3, which involves analysis of relevant data, strength of overall evidence, and conclusions about performance and safety. The flowchart ends with the production of a clinical evaluation report. *Conformity to harmonized performance standards may be sufficient to demonstrate compliance to relevant Essential Requirements (ERs) SECTION 05 PAGE 8 OF 9 {11}------------------------------------------------ Image /page/11/Picture/1 description: The image contains the logo for GPC Medical Ltd. The logo includes the text "GPC Medical Ltd." in green, along with the text "Govt. of India Recognized Star Export House" in black. To the right of the company name is the text "The Best Name in India in its field", along with the text "Backed by experience since 1930", and certifications such as "ISO 9001:2008 Certified" and "ISO 13485:2003 Certified". Based on the following aspects a literature survey and conclusion has been drawn and there is no need to have clinical evaluation done as the device is substantially equivalent to the predicate devices already in the US Market for more than 10 years. # CONCLUSION BASED ON THE CLINICAL AND NON-CLINICAL TESTING DATA: From the available data, we at GPC demonstrate that GPC Intramedullary Nailing Systems are 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 our devices can be considered safe and effective for their intended use. SECTION 05