(409 days)
Not Found
No
The 510(k) summary describes a mechanical intramedullary nailing system and its components. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts. The performance studies focus on material and mechanical properties.
Yes.
The device is used for treating fractures and stabilizing bones, which are therapeutic interventions.
No
The device is an intramedullary nailing system used for treating and stabilizing bone fractures, not for diagnosing them.
No
The device description clearly states that the GPC Intraheal Intramedullary Nailing System is manufactured using stainless steel or titanium materials and includes physical components like nails, locking bolts, end caps, and K-wires. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the GPC Intraheal Intramedullary Nailing System is for treating fractures of various bones. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is described as intramedullary nails, locking bolts, end caps, and K-wires made of surgical implant materials. These are physical implants used to stabilize bone fractures.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on the mechanical properties of the implants (bending, fatigue, torsion, pull-out), which are relevant to their function as bone fixation devices, not diagnostic tools.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The GPC Intraheal Intramedullary Nailing System is used in vivo (inside the body) for a therapeutic purpose (fixing fractures).
N/A
Intended Use / Indications for Use
GPC Intraheal Intramedullary Nailing System are provided non-sterile. GPC Intraheal Intramedullary Nailing System are indicated for treating fractures of various bones as given below:
Multi Angle Femoral Nail: The indications for Use of Multi Angle Femoral Nails are as given below:
- To Stabilize Femoral shaft fractures, Subtrochanteric Fractures, Ipsilateral Neck and Shaft Fracturers, Impending Pathologic Fractures, Nonunions and Malunions.
Proximal Hip Stabilizing Nail 3: The indications for Use of Proximal Hip Stabilizing Nail 3 are as given below: Short Nail Indications: -
- Fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion .
- and tumor resections .
Long Nail Indications: -
- . Indications may include fractures resulting from trauma, nonunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.
Elastic Nails:
The Elastic Nail is indicated for fixation of diaphyseal fractures of the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures and lower extremity fractures in paediatic or small statured patients. In paediatric application, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.
K-Wires:
K-wires are indicated to perform as fixation and stabilization unit of bone fractures or as guide at insertion of implants into the skeletal system
All implants are for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HSB, HWC, JDS, HTY, JDW
Device Description
GPC Intraheal Intramedullary Nailing System are manufactured in various shapes and sizes. The intramedullary nails are fixed with corresponding sizes of locking bolts and end caps. GPC Intraheal Intramedullary Nailing System are manufactured using stainless steel or titanium materials for surgical implant applications.
The different sizes and model numbers of GPC Intraheal Intramedullary Nailing System are based on the site of application such as fixation or reconstruction of the bones. These intramedullary nails are available in different diameters and lengths to suit the patient anatomy and size of the bones.
GPC Intraheal Intramedullary Nailing System are typically divided into following three categories:
-
- Femoral Nails and corresponding locking bolts and end cap for fixation
-
- Elastic Nails and corresponding end caps for fixation
-
- K wire for fixation
The specific names of the GPC Intraheal Intramedullary Nails are as given below:
Multi Angle Femoral Nail
Proximal Hip Stabilizing Nail 3 (Also called as PHN3)
Elastic Nail
K.Wire
These implants are supplied non-sterile, the products have to be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral shaft, Subtrochanteric, Ipsilateral Neck and Shaft (Femur), Intertrochanteric (Hip), long bones (upper extremity fractures and lower extremity fractures), bones (general).
Indicated Patient Age Range
Paediatric (for Elastic Nails in lower extremity fractures).
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed against applicable product standards.
Material Standards: ASTM F136 (Titanium-6 Vanadium ELI Alloy), Stainless Steel 316L, Stainless Steel 316LVM. The purchased material complies with these standards.
Performance Standards for Intramedullary Nails: Testing performed per ASTM F1264 and ASTM F 384. Results: Static Four Point Bend Test: Conforms; Bending Fatique Properties: Conforms; Static Torsional Testing: Conforms; Compression Bending: Conforms.
Performance Standards for Bone Screws: Testing performed per ASTM F 543. Results: Torsional Properties: Conforms, Driving Torque: Conforms, Pull-out Test: Conforms.
Performance Standards for Bone Wires: Tensile Testing per ASTM F 136 and ASTM F 138. Results: Conforms.
Clinical evaluation was not necessary as the device is of similar design, pattern, and intended use as predicate devices already on the market and in clinical use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes Lateral Entry Femoral Nail (K040336), GPC Tibial Nail System Ex (K143245), Synthes Trochanteric Fixation Nail (TFN) SYSTEM (K011857), Gamma 3 Nail System (K043431), Synthes Elastic Intramedullary Nail (EIN) System (K971783), Synthes Elastic Intramedullary Nail (EIN) End Cap K053105, SMT Schilling Metalltechnik GmbH (K100736)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
February 10, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters 'FDA' in white. Further to the right, the words 'U.S. FOOD & DRUG' are written in blue, with 'ADMINISTRATION' written in a smaller font size below.
GPC Medical Limited Vikas Narang Director GPC Square, M-Block, DDA LSC, Vikas Puri, New Delhi New Delhi, Delhi 110018 India
Re: K203811
Trade/Device Name: GPC Intraheal Intramedullary Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC, JDS, HTY, JDW Dated: January 12, 2022 Received: January 14, 2022
Dear Vikas Narang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Jiping Chen. M.D., Ph.D., M.P.H. Acting Division Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality 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) K203811
Device Name GPC Intraheal Intramedullary Nailing System
Indications for Use (Describe)
GPC Intraheal Intramedullary Nailing System are provided non-sterile. GPC Intraheal Intramedullary Nailing System are indicated for treating fractures of various bones as given below:
Multi Angle Femoral Nail: The indications for Use of Multi Angle Femoral Nails are as given below:
- To Stabilize Femoral shaft fractures, Subtrochanteric Fractures, Ipsilateral Neck and Shaft Fracturers, Impending Pathologic Fractures, Nonunions and Malunions.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203811
Device Name GPC Intraheal Intramedullary Nailing System
Indications for Use (Describe)
Proximal Hip Stabilizing Nail 3: The indications for Use of Proximal Hip Stabilizing Nail 3 are as given below: Short Nail Indications: -
- Fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion .
- and tumor resections .
Long Nail Indications: -
- . Indications may include fractures resulting from trauma, nonunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
즈 Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
Page 1 of 1
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203811
Device Name GPC Intraheal Intramedullary Nailing System
Indications for Use (Describe)
Elastic Nails:
The Elastic Nail is indicated for fixation of diaphyseal fractures of the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures and lower extremity fractures in paediatic or small statured patients. In paediatric application, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate. K-Wires:
K-wires are indicated to perform as fixation and stabilization unit of bone fractures or as guide at insertion of implants into the skeletal system
All implants are for single use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
5
C Medical Ltd
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 Limited. |
|---|---|
| Address: | Office :GPC Square, M-Block, DDA, LSC, VikasPuri New Delhi, |
| 110018 INDIA. | |
| Factory : Plot C-3, Sec B-1, UPSIDC, Trans Delhi Signature City, | |
| Loni, Ghaziabad, UP 201102 | |
| Contact Person Name: | Mr. Vikas Narang |
| Title: | Director |
| Phone Number: | +91-9810638797 |
| Dated: | 16-12-2020 |
This is a bundled submission.
Throughout the submission there is a mention of GPC Intraheal Intramedullary Nailing 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:
-
. GPC Intraheal Intramedullary Nailing System.
Common or Usual Name: -
Orthopaedic Bone Nail ●
-
. Orthopaedic Bone Screw
-
Orthopaedic Bone Wire
Classification Name:
- NAIL,FIXATION,BONE
- . SCREWS,FIXATION, BONE
- WIRE, FIXATION, BONE .
Product Code: HSB, HWC, JDS, HTY, JDW
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C Medical Ltd
Device Class: Il
Review Pane: Orthopaedic
Regulation Number: 21CFR888.3020, 21CFR888.3030 and 21CFR888.3040
Device Details:
GPC Intraheal Intramedullary Nailing System are manufactured in various shapes and sizes. The intramedullary nails are fixed with corresponding sizes of locking bolts and end caps. GPC Intraheal Intramedullary Nailing System are manufactured using stainless steel or titanium materials for surgical implant applications.
The different sizes and model numbers of GPC Intraheal Intramedullary Nailing System are based on the site of application such as fixation or reconstruction of the bones. These intramedullary nails are available in different diameters and lengths to suit the patient anatomy and size of the bones.
GPC Intraheal Intramedullary Nailing System are typically divided into following three categories:
-
- Femoral Nails and corresponding locking bolts and end cap for fixation
-
- Elastic Nails and corresponding end caps for fixation
-
- K wire for fixation
The specific names of the GPC Intraheal Intramedullary Nails are as given below:
Multi Angle Femoral Nail Proximal Hip Stabilizing Nail 3 (Also called as PHN3) Elastic Nail K.Wire
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. | Multi Angle Femoral Nail | Synthes Lateral Entry Femoral Nail (K040336) |
| Locking Bolts 6.5mm (Self Tapping) | Synthes Lateral Entry Femoral Nail (K040336) (Synthes LFN) | |
| Locking Bolt 4.9mm, Self Tapping | GPC Tibial Nail System Ex (K143245) and Synthes Trochanteric Fixation Nail (TFN) SYSTEM (K011857) |
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C Medical Ltd
| 02. | Proximal Hip Stabilizing Nail 3 (Short and Long) | Gamma 3 Nail System (K043431) |
|---|---|---|
| Cephalic Screw for Proximal Hip Stabilizing Nail 3 | Gamma 3 Nail System (K043431) | |
| Locking Bolt 5.0mm | Gamma 3 Nail System (K043431) | |
| 03. | Elastic Nail Titanium | Synthes Elastic Intramedullary Nail |
| (EIN) System (K971783) | ||
| End Cap of Elastic Nail Titanium | Synthes Elastic Intramedullary Nail | |
| (EIN) End Cap K053105 | ||
| 04. | K. Wire | SMT Schilling Metalltechnik GmbH |
| (K100736) |
NOTE: The end cap of each type of intramedullary nail is also part of the corresponding intramedullary nail and no separate predicate device is applicable for the end caps.
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 of GPC Intraheal Intramedullary Nailing System:
There are following types of Bone Nails used with Locking Screws and Bolt and Wires. The Bone Nails are generally designed on the basis of the bones.
| S. No. | Type | Variants | Angles | Diameters | Lengths | Material of
Construction |
|--------|------------------------------------------|----------------------------------------------|------------------------------------------|----------------------|-------------------|---------------------------------|
| 1. | Multi Angle
Femoral
Nail | With Left
and Right
Versions | -- | 9mm to
12mm | 300mm to
460mm | Stainless Steel
and Titanium |
| 2. | Proximal
Hip
Stabilizing
Nail 3 | Short | 120 degree,
125 degree,
130 degree | 10mm, 11mm
& 12mm | 180mm to
220mm | Stainless Steel
and Titanium |
| | | Long( with
Left and
Right
Versions) | 120 degree,
125 degree,
130 degree | 10mm, 11mm
& 12mm | 300mm to
480mm | Stainless Steel
and Titanium |
| 3. | Elastic Nail
Titanium | -- | -- | 2.0mm to
4.0mm | 440mm | Titanium |
8
PC Medical Ltd
| 4. | K. Wire
Diameter 1.0mm to 4.5mm with length: 100 to 300mm | With Partial Thread, Single Side Trocar, Both Side Trocar | -- | 1.0-4.5mm | 100mm to 300mm | Stainless Steel and Titanium |
|----|--------------------------------------------------------------|-----------------------------------------------------------|----|-----------|----------------------------------------------------------------------------------------------------|------------------------------|
| 5. | Locking Bolts 4.9 mm, self-tapping | -- | -- | 4.9mm | 26-60mm(
2mm
increment),
(64-80mm) 4
mm
increment
(80-100mm)
5mm
increment | Stainless Steel and Titanium |
| 6. | Self Tapping Locking Bolts 6.5mm | -- | -- | 6.5mm | 60mm to 130mm in 5 mm increments | Stainless Steel and Titanium |
| 7. | Locking Bolts 5.0 mm, self-tapping | -- | -- | 5.0mm | 26mm to 60mm with 2mm increment and 60 to 120mm with 5 mm increment | Stainless Steel and Titanium |
| 8. | Cephalic Screw | -- | -- | 10.5mm | 70mm-130mm with 5mm increments | Stainless Steel and Titanium |
These implants are supplied non-sterile, the products have to be sterilized prior to use.
A5).A statement of the intended use of the device
Indications for Use:
GPC Intraheal Intramedullary Nailing System are provided non-sterile.
GPC Intraheal Intramedullary Nailing System are indicated for treating fractures of various bones as given
9
edical Lt
below:
Multi Angle Femoral Nail: The indications for Use of Multi Angle Femoral Nails are as given below:
-To Stabilize Femoral shaft fractures, Subtrochanteric Fractures, Ipsilateral Neck and Shaft Fracturers,
Impending Pathologic Fractures, Nonunions and Malunions.
Proximal Hip Stabilizing Nail 3: The indications for Use of Proximal Hip Stabilizing Nail 3 are as given below:
Short Nail Indications: -
•Fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections
- Long Nail Indications:-
•Indications may include fractures resulting from trauma, nonunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.
Elastic Nails:
The Elastic Nail is indicated for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in paediatric or small statured patients. In paediation, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.
K-Wires:
K-wires are indicated to perform as fixation and stabilization unit of bone fractures or as guide at insertion of implants into the skeletal system
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 Intraheal Intramedullary Nailing System and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.
Following is the summary of parameters in which the comparison has been verified:
| S. No. | Characteristics | Predicate Device Versus New (GPC Intraheal
Intramedullary Nailing System) | Remarks on
Equivalence |
|--------|------------------------------|------------------------------------------------------------------------------|---------------------------|
| 01 | Regulatory
Classification | Same Classification and
Regulation Number | Equivalent |
| 02 | Indications for use | Similar intended use in New Device
and Predicate device | Equivalent |
10
| 03 | Material | Both the predicate and subject
devices use material meant for
surgical implant application | Equivalent |
|----|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 04 | Performance
Standards | Same performance standards used
in both New Device as well as
predicate device | Equivalent |
| 05 | Sterilization | Same method of sterilization used
in both New Device as well as
Predicate device | Equivalent |
| 06 | Dimensional
Verification | Similar dimensions found in both
New
Device as well as Predicate device
The minor differences that exist, do
not raise any safety concerns. | Equivalent |
b1).Discussion on the non-clinical testing performed
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 to following material standards
-
ASTMF136: Standard specification for wrought Titanium-6 VanadiumELI (Extra low interstitial) Alloy for surgical implant applications.
-
Stainless Steel 316L and Stainless Steel 316LVM
The purchased material are in compliance to these standards.
B: Performance Standards:
The device performance of GPC Intramedullary Nailing System has been demonstrated against following applicable standards
11
edical Lt
For Intramedullary Nails:
- The testing performed As per ASTMF1264 and ASTM F 384 ●
Static Four Point Bend Test: Conforms
Bending Fatique Properties: Conforms
Static Torsional Testing: Conforms
Compression Bending: Conforms
For Bone Screws:
- The Testing Performed As per ASTMF 543: . Torsional Properties: Conforms, Driving Torque :Conforms, Pull-out Test: Conforms
For Bone Wires:
Tensile Testing as per ASTM F 136 and ASTM F 138: Conforms
b2). Discussion on the clinical evaluation referenced and relied up on:
GPC Intraheal Intramedullary Nailing System are of similar design and pattern as well as similar intended use as that of predicate devices which are in market already and in clinical use. Therefore Clinical information was not necessary to demonstrate substantial equivalence.
12
GPC Medical Ltd
CONCLUSION:
General, Safety and Performance conclusion:
From the available data available we can justify that the GPC Intraheal Intramedullary Nailing System 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 these devices can be considered safe and effective for their intended use.