(372 days)
Not Found
No
The device description and intended use clearly define the device as traditional bone plates and screws made of stainless steel and titanium, used for fracture fixation. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The performance studies are based on standard mechanical testing of the physical implants.
Yes
The device aids in the treatment of fractures, which is a therapeutic purpose.
No
Explanation: The device, AUXEIN Brand of Bone plates and bone screws, including the DCS plate system and Locking Plates/Screws, is intended for treating fractures by providing fixation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it consists of physical bone plates and screws made of stainless steel and titanium, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The description clearly states that this device consists of "Bone plates and bone screws," "DCS plate system," and "Locking Plates and Locking screws." These are implants designed to be surgically placed inside the body to fix fractures.
- Intended Use: The intended use is to "treat fractures of various bones." This is a therapeutic intervention performed in vivo (inside the body).
The information provided describes a surgical implant system used for orthopedic procedures, not a device for testing biological samples.
N/A
Intended Use / Indications for Use
AUXEIN Brand of Bone plates and bone screws are provided non-sterile. AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System, AUXEIN brand of Locking Plates and Locking Screws. AUXEIN Brand of Bone plates and bone screws are provided non-sterile. AUXEIN Brand of bone screws are intended for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus,ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges). AUXEIN Brand of DCS plate system is used to provide fixation of fractures to the proximal femur and generally indicated for use in trochanteric, pertrochanteric, intertrochanteric fractures. The system is indicated for use in adult patients only. All implants are for single use only. AUXEIN brand of Locking Plates and Locking screws have the same indications for use as mentioned above with additional feature of locking by way of combination threads in plates and corresponding Screws.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
Auxein Brand of Bone Plates and Bone Screws, Auxein Brand of DCS Plate System, Auxein Brand of Locking Plates and Locking Screws system consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws, compression and dynamic screws, The plates and screws are fabricated from stainless steel and titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available: like, Reconstruction Plates, , T- Plates, , Anatomical Plates, Clavicle Hook Plates. These all are mainly divided into . Mini Fragment Plates . Small Fragment Plates Large Fragment Plates . DCS Plates. ● The thickness of the plates varies from 1.0mm to 6mm; and the number of the holes varies from 2 to 22. The screw implants are in corresponding diameter ranges from 2.4mm, 2.7mm, 5.0mm diameters with lengths varying as per the requirements and minimum length: 6 mm to maximum length 90mm These implants are sold 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
clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges), proximal femur shaft
Indicated Patient Age Range
adult patients only
Intended User / Care Setting
Not Found
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.
Material Standards:
- ASTM F 136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
- ASTM F 138: Standard Specification for Wrought 18 chromium-14Nickel-2.5Molybdenum stainless steel bar and wire for surgical implants.
- ASTM F 139: Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants
Performance Standards (for Bone Plates):
- ASTM F 382: Static Four Point Bend Test: Conforms
- ASTM F 384: Dynamic Four Point Bend Test: Conforms
Performance Standards (for Bone Screws):
- ASTM F 543: Torsional Properties: Conforms, Driving Torque: Conforms, Pull-out Test: Conforms
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.
K012114, K040777, K033995, K001945, K041860, K082807, K000684, K030597, K011978, K092812, K061753, K092609, K051986, K062564, K030858, K033975, K000682
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
§ 888.3030 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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2015
Auxien Medical Rahul Luthra Director 103, First Floor Jyoti Bhawan Commercial Complex Mukherjee Nagar New Delhi, India 110009
Re: K141680
Trade/Device Name: AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws 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: May 15, 2015 Received: May 21, 2015
Dear Mr. Rahul Luthra:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
1
Page 2 - Mr. Rahul Luthra
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); 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 vou 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141680
Device Name
AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws
Indications for Use (Describe)
AUXEIN Brand of Bone plates and bone screws are provided non-sterile.
AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System, AUXEIN brand of Locking Plates and Locking Screws.
AUXEIN Brand of Bone plates and bone screws are provided non-sterile. AUXEIN Brand of bone screws are intended for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus,ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).
AUXEIN Brand of DCS plate system is used to provide fixation of fractures to the proximal femur and generally indicated for use in trochanteric, pertrochanteric, intertrochanteric fractures.
The system is indicated for use in adult patients only. All implants are for single use only.
AUXEIN brand of Locking Plates and Locking screws have the same indications for use as mentioned above with additional feature of locking by way of combination threads in plates and corresponding Screws.
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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3
Premarket Notification 510(k) Summary as required by Section 807.92
General Company Information as required by 807:92 (a)
(a.1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared
| Submitter's Name: | Auxein Medical |
|---|---|
| Address: | |
| Office: | 103, First Floor, |
| Jyoti Bhawan, Comm. Complex, | |
| Dr. Mukherjee Nagar, | |
| Delhi – 110009 (INDIA) | |
| Factory: | Auxein Medical Pvt. Ltd. |
| Plot Number 169-170, HSIIDC, | |
| Industrial Area, Kundli, | |
| District Sonepat, | |
| Haryana 131028 (India) | |
| Contact Person Name: | Mr. Rahul Luthra |
| Title: | Director |
| Phone Number: | +91-9811720999 |
| Dated: | 10-06-2014 |
This is a bundled submission.
Throughout the submission there is a mention of Auxein Brand of Bone Plates and Bone Screws that represents the range of products covered under this 510(k) submission.
4
a.2: The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
Proprietary Name:
- Auxein brand of bone plates and bone screws & auxein brand of DCS plate . system
- Auxein brand of locking plates and locking screws .
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 Pane: Orthopaedic
Regulation Number: 21 CFR 888.3030 and 21 CFR 888.3040
Variants/Types:
Auxein Brand of Bone Plates and Bone Screws, Auxein Brand of DCS Plate System and Auxein Brand of Locking Plates and Locking Screws are further subdivided into following categories
| S. No. | Category | Types |
|---|---|---|
| 01 | Mini Fragment Plates | Locking Version |
| 02 | Small Fragment Plates | Locking Version |
| 03 | Large Fragment Plates | Locking Version |
| 04 | Bone Screws | Locking Version |
5
Further Description of Auxein Brand Bone Plates and Bone Screws, Auxein Brand of DCS Plate System and Auxein Brand of Locking Plates and Locking Screws system
Generally there are following types of bone plates:
- Dynamic Compression Type, .
- . Special (for particular bones)
- Mini fragment •
The aforementioned plates are used with cortical (cortex)-Locking Screws.
These bone plates are generally designed on the basis of the bone contour and anatomy.
| S. No. | Type | Subtype |
|---|---|---|
| 01 | Mini Fragment | T-Shaped |
| 02 | Small and Large | |
| Fragment | T-Shaped, Hook, Angled Plates. Reconstructions | |
| plates | ||
| 03 | Dynamic | |
| compression | Small DCP, Narrow DCP, Lengthening Narrow, Broad | |
| DCP, Lengthening Broad Plates | ||
| 04 | DCS | DCS Plate |
6
A3) Identification of the Predicate Device:
Following are the predicate device 510(k) with which we are declaring substantial equivalence:
Following is the range of variants covered with their corresponding predicate devices.
| S.N. | Item Description | Predicate Device |
|---|---|---|
| 1. | 2.4mm Wise-Lock "T" Distal Radius Dorsal | |
| Plate, (3 Head Holes) | K012114 (Synthes locking distal | |
| radius plating system) | ||
| 2. | 2.4mm Wise-Lock Distal Radius Volar | |
| Plate, Extra-Articular, Left, (4 Head Holes) | LCP Radial Head Plating | |
| System (K040777) | ||
| 3. | 2.4mm Wise-Lock Distal Radius Volar | |
| Plate, Extra-Articular, Right, (4 Head Holes) | LCP Radial Head Plating | |
| System (K040777) | ||
| 4. | 2.7/3.5mm Wise-Lock Dorsolateral Distal | |
| Humerus Plate, Left Direction | Synthes 3.5mm LCP Distal | |
| Humerus System (K033995) | ||
| 5. | 2.7/3.5mm Wise-Lock Dorsolateral Distal | |
| Humerus Plate, Right Direction | Synthes 3.5mm LCP Distal | |
| Humerus System (K033995) | ||
| 6. | 2.7/3.5mm Wise-Lock Dorsolateral Distal | |
| Humerus Plate with Lateral Support, Left | ||
| Direction | Synthes 3.5mm LCP Distal | |
| Humerus System (K033995) | ||
| 7. | 2.7/3.5mm Wise-Lock Dorsolateral Distal | |
| Humerus Plate with Lateral Support, Right | ||
| Direction | Synthes 3.5mm LCP Distal | |
| Humerus System (K033995) | ||
| 8. | 2.7/3.5mm Wise-Lock Medial Distal Tibia | |
| Plate, Left Direction | Synthes Medial Distal Tibia Plate | |
| (K001945) | ||
| 9. | 2.7/3.5mm Wise-Lock Medial Distal Tibia | |
| Plate, Right Direction | Synthes Medial Distal Tibia Plate | |
| (K001945) | ||
| 10. | PHEELOS - Wise-Lock Proximal Humerus | |
| Plate | Synthes (USA) LCP® Proximal | |
| Humerus Plates, Long | ||
| (K041860) | ||
| 11. | 3.5mm Wise-Lock Small Dynamic | |
| Compression Plate with LC under cuts | Synthes 3.5 and 4.5mm Locking | |
| Compression Plate System | ||
| (K082807) | ||
| 12. | 3.5mm Wise-Lock Proximal Humerus Plate | Proximal humerus plate long |
| Synthes K041860 | ||
| 13. | 3.5mm Wise-Lock Small 'T' Plate, Oblique | |
| Angled - Left Direction | Synthes Small Fragment Dynamic | |
| Compression Locking(DCL) | ||
| System (K000684) | ||
| 14. | 3.5mm Wise-Lock Small 'T' Plate, Oblique | |
| Angled - Right Direction | Synthes Small Fragment Dynamic | |
| Compression Locking(DCL) | ||
| System (K000684) | ||
| 15. | 3.5mm Wise-Lock Small 'T' Plate, Right | |
| Angled (3 Head Holes) | Synthes Small Fragment Dynamic | |
| Compression Locking(DCL) | ||
| System(K000684) | ||
| 16. | Wise-Lock Small 'T' Plate, Right Angled (4 | |
| Head Holes) | Synthes Small Fragment Dynamic | |
| Compression Locking(DCL) | ||
| System(K000684) | ||
| 17. | 3.5mm Wise-Lock Proximal Tibia Plate, Left | |
| Direction | Synthes 3.5mm Titanium LCP | |
| Proximal Tibia Plate (K030597) | ||
| OR Synthes LCP Proximal Tibia | ||
| Plates (K011978) | ||
| 18. | 3.5mm Wise-Lock Proximal Tibia Plate, | |
| Right Direction | Synthes 3.5mm Titanium LCP | |
| Proximal Tibia Plate (K030597) | ||
| OR Synthes LCP Proximal Tibia | ||
| Plates (K011978) | ||
| 19. | 3.5mm Wise-Lock Anterolateral Distal Tibia | |
| Plates, Left | Synthes (USA) 2.7mm / 3.5mm | |
| LCP Anterolateral Distal Tibia | ||
| Plates (K092812) | ||
| 20. | 3.5mm Wise-Lock Anterolateral Distal Tibia | |
| Plates, Right | Synthes (USA) 2.7mm / 3.5mm | |
| LCP Anterolateral Distal Tibia | ||
| Plates (K092812) | ||
| 21. | 3.5mm Wise-Lock Clavicle Hook Plate, Left | |
| Direction | Synthes Clavicle Hook Plate | |
| (K061753) | ||
| 22. | 3.5mm Wise-Lock Clavicle Hook Plate, | |
| Right Direction | Synthes Clavicle Hook Plate | |
| (K061753) | ||
| 23. | 4.5/5.0mm Wise Lock Broadly Curved | |
| Plates | Synthes 3.5 mm and 4.5 mm | |
| Curved Narrow and Broad | ||
| Locking Compression Plates | ||
| (LCP) (K092609) | ||
| 24. | 4.5/5.0mm Wise-Lock Reconstruction | |
| Plates | Synthes 4.5 mm LCP Straight | |
| Reconstruction Plate (K051986) | ||
| 25. | 4.5/5.0mm Wise Lock Broad Locking | |
| Compression Plate | Synthes 3.5 and 4.5mm Locking | |
| Compression Plate System | ||
| (K082807) | ||
| 26. | 4.5/5.0mm Wise Lock Narrow Locking | |
| Compression Plate | Synthes 3.5 and 4.5mm Locking | |
| Compression Plate System | ||
| (K082807) | ||
| 27. | 4.5/5.0mm Wise lock Distal Femur Plate | Synthes LCP Distal Femur |
| Plates (K062564) | ||
| 28. | 4.5/5.0mm Wise Lock Lateral Tibia Plate | Synthes LCP Proximal Tibia |
| Plate (K011978) | ||
| 29. | 4.5/5.0mm Wise Lock Proximal Femur plate | Synthes (USA) LCP Proximal |
| Femur Plate and Screws | ||
| (K030858) | ||
| 30. | 2.4mm Wise Lock Screw | Synthes |
| 2.4mm titanium locking screw | ||
| (K033975) | ||
| 31. | 2.7 mm Wise Lock Screw | Synthes Small Fragment |
| Dynamic Compression Locking | ||
| (DCL) System (K000684) | ||
| 32. | 3.5mm Wise lock screw | Synthes Small Fragment |
| Dynamic Compression Locking | ||
| (DCL) System (K000684) | ||
| 33. | 5.0mm Wise lock Screw | Synthes Large Fragment |
| Dynamic Compression Locking | ||
| (DCL) System (K000682) |
7
8
9
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:
Plate Fixation System
Auxein Brand of Bone Plates and Bone Screws, Auxein Brand of DCS Plate System, Auxein Brand of Locking Plates and Locking Screws system consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws, compression and dynamic screws,
The plates and screws are fabricated from stainless steel and titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available: like, Reconstruction Plates, , T- Plates, , Anatomical Plates, Clavicle Hook Plates.
These all are mainly divided into
- . Mini Fragment Plates
- . Small Fragment Plates
- Large Fragment Plates .
- DCS Plates. ●
The thickness of the plates varies from 1.0mm to 6mm; and the number of the holes varies from 2 to 22.
The screw implants are in corresponding diameter ranges from 2.4mm, 2.7mm, 5.0mm diameters with lengths varying as per the requirements and minimum length: 6 mm to maximum length 90mm
These implants are sold non-sterile, the products have to be sterilized prior to use.
10
A5). (5) A statement of the intended use of the device
Indications for Use:
·AUXEIN Brand of Bone plates and bone screws are provided non-sterile.
AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System, AUXEIN brand of Locking Plates and Locking Screws.
AUXEIN Brand of Bone plates and bone screws are provided non-sterile. AUXEIN Brand of bone plates and bone screws are intended for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus,ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).
AUXEIN Brand of DCS plate system is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, pertrochanteric fractures. The system is indicated for use in adult patients only. All implants are for single use only.
AUXEIN brand of Locking Plates and Locking screws have the same indications for use as mentioned above with additional feature of locking by way of combination threads in plates and corresponding Screws.
11
a6). Summary of Technological Characteristics as compared to the predicate devices:
Substantial equivalence including comparison with predicate devices
A comparison between the Auxein Brand of Bone Plates and Bone Screws, Auxein Brand of DCS Plate System, Auxein Brand of Locking Plates and Locking Screws 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
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 |
| 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 |
12
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
-
- ASTM F 136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
-
- ASTM F 138: Standard Specification for Wrought 18 chromium-14Nickel-2.5Molybdenum stainless steel bar and wire for surgical implants.
-
- ASTM F 139: Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants
We have verified the purchased material compliance to these standards and copies of the relevant test results were provided in the submission.
B: Performance Standards:
The device performance of Auxein Brand of Bone Plates and Bone Screws, Auxein Brand of DCS Plate System and Auxein Brand of Locking Plates and Locking Screws has been demonstrated against following applicable 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:
As per ASTM F 543 :Torsional Properties: Conforms, Driving Torque : Conforms, Pull-out Test: Conforms
13
b2). Discussion on the clinical evaluation referenced and relied upon:
Auxein Brand of devices are of similar design and pattern as well as similar intended use. Clinical information was not necessary to demonstrate substantial equivalence.
CONCLUSION:
General, Safety and Performance conclusion:
From the available data available we can justify that the Auxein Brand of Bone Plates and Bone Screws, Auxein Brand of DCS Plate System and Auxein Brand of Locking Plates and Locking Screws are as safe, as effective and perform as same indications for use as that of already marketed predicate devices identified in a3. of 510(k) summary.
Hence our devices can be considered safe and effective for their intended use.