(318 days)
2.4mm Wise-Lock Distal Radius System:
2.4mm Wise-Lock Distal Radius System are used for displaced extra-articular distal radius fractures and corrective osteotomies of the distal radius.
2.4mm Wise-Lock Proximal Radius System:
2.4mm Wise-Lock Proximal Radius System are used for extra-articular fractures of Proximal radius and multifragmented radial neck fractures.
2.4mm Variable Angle Distal Radius System:
2.4mm Variable Angle Distal Radius System are used for displaced extra-articular and intra-articular distal radius fractures and corrective osteotomies of the distal radius.
The 2.4mm Radius System consists of various types of bone plates, screws for implantation in the radius bone to treat the radius bone fracture.
The provided text describes a 510(k) premarket notification for a medical device called the "2.4mm Radius System." This is a submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device, and thus does not require approval of a premarket approval application (PMA).
Crucially, this document focuses on demonstrating substantial equivalence based on design, materials, and mechanical performance tests against recognized standards, rather than clinical performance or diagnostic accuracy. Therefore, the concepts of acceptance criteria for diagnostic performance, test set characteristics, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this type of regulatory submission.
The "acceptance criteria" in this context refer to compliance with material standards, mechanical performance standards, and sterilization/packaging standards. The "study that proves the device meets the acceptance criteria" refers to the non-clinical bench testing conducted against these standards.
Here's a breakdown of the requested information based on the provided text, noting where certain categories are not applicable:
Acceptance Criteria and Study Details for the 2.4mm Radius System (K211324)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Material Standards | - ASTM F136/ISO 5832-3: Standard specification for wrought Titanium-6 Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.- ASTM F899-12: Standard Specification for Wrought Stainless Steels for surgical instruments.- ASTM F138/ISO 5832-1: Standard Specification for Wrought-18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants. | - Compliance verified with Titanium Alloy (Ti-6Al-4V) Grade 5 as per ISO 5832-1/ASTM F136 for Titanium Implants.- Compliance verified with Stainless Steel (Grade 316L) as per ISO 5832-3/ASTM F138 for Stainless Steel Implants.- Compliance verified with Grade 304 of Stainless steel (SS 304) Material for instruments as per ASTM F899-12b. |
| Mechanical Performance | - ASTM F382: Standard Specification and Test Method for Metallic Bone Plates.- ASTM F543: Standard Specification and Test Method for Metallic Medical Bone Screws. | Plate Testing: - 4-Point Static Test: Conforms - 4-Point Fatigue Test: ConformsScrew Testing: - Driving Torque Test: Conforms - Torsion Test: Conforms - Axial Pull-out Test: Conforms |
| Biocompatibility | - ISO 10993-3 (General evaluation for raw materials) | Raw materials evaluated and found to comply with ISO 10993-3. |
| Sterilization & Packaging | - ISO 11137-1, -2, -3 (Radiation sterilization)- ISO 17665-1, -2, -3 (Moist heat sterilization)- ISO 11140-1 (Chemical indicators)- ISO 11737-1, -2 (Microbiological methods)- ISO 11607-1, -2 (Packaging for sterile medical devices)- ASTM F1980 (Accelerated Aging of Sterile Barrier Systems)- ASTM F88/F88M (Seal strength)- ASTM F1929 (Seal leaks by dye penetration) | Subject device and packaging validated against these standards for both Gamma Sterilization and non-sterile products. |
| Bacterial Endotoxin | - USP <85> Bacterial Endotoxin Test.- USP <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests. | Compliance with USP <85> and <161> for bacterial endotoxin and pyrogen tests. |
| Dimensional Verification | Comparison to predicate device dimensions. | Same dimension as of Predicate device. |
| Shelf-life | 5 Years | 5 Years (Same as predicate device) |
| Use Type | Single Use | Single Use (Same as predicate device) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document describes bench testing for mechanical integrity and material compliance, not clinical or diagnostic performance on human or animal subjects. The "sample size" would refer to the number of test coupons or devices subjected to mechanical tests (e.g., how many plates for 4-point static test, how many screws for torsion test). This specific number is not explicitly stated in the provided text, but it is implied that a sufficient number was tested to meet the requirements of the ASTM standards.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): The data provenance here refers to the origin of the bench test results. These tests were conducted as part of the manufacturer's (Auxein Medical Private Limited, India) submission to the FDA. The tests likely involved physical samples of the manufactured devices. The data itself is prospective in the sense that the tests were performed specifically for this submission against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a bone fixation system (medical hardware), not a diagnostic algorithm that requires expert interpretation to establish a ground truth. The "ground truth" for this device relates to its material properties and mechanical performance, which are established by standardized laboratory testing methods and engineering specifications, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As this is not a diagnostic performance study, there's no need for an adjudication method for establishing ground truth. The compliance with standards is determined by objective measurements during bench testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a bone fixation device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (bone plate and screws), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device is defined by established engineering and material standards (e.g., ASTM F382, ASTM F543, various ISO and ASTM material standards). Compliance with these standards confirms the device's functional and material integrity.
8. The sample size for the training set
- Not Applicable. This device is not an AI/machine learning algorithm, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
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March 14, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Auxein Medical Private Limited % Gaurav Luthra Director Auxein Medical Pvt. Ltd. Plot No 168-169-170 Sector 57, Phase IV, HSIIDC Kundli Sonepat, Haryana 131028 India
Re: K211324
Trade/Device Name: 2.4mm Distal Radius 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: February 9, 2022 Received: February 11, 2022
Dear Gaurav 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. 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
{1}------------------------------------------------
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 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-reporting-
combination-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 medical devices and radiation-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: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211324
Device Name 2.4mm Radius System
Indications for Use (Describe)
2.4mm Wise-Lock Distal Radius System:
2.4mm Wise-Lock Distal Radius System are used for displaced extra-articular distal radius fractures and corrective osteotomies of the distal radius.
2.4mm Wise-Lock Proximal Radius System:
2.4mm Wise-Lock Proximal Radius System are used for extra-articular fractures of Proximal radius and multifragmented radial neck fractures.
2.4mm Variable Angle Distal Radius System:
2.4mm Variable Angle Distal Radius System are used for displaced extra-articular and intra-articular distal radius fractures and corrective osteotomies of the distal radius.
| 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)
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Section 5.0: 510K Summary
Pre Market 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 Private Limited |
|---|---|
| Address: | Auxein Medical Private LimitedPlot No. 168-169-170, Phase-4, Kundli Industrial Area, HSIIDC,Sector-57, Sonepat-131028, Haryana, India |
| Contact Person Name: | Mr. Rahul Luthra |
| Title: | Director |
| Phone Number: | +91-9811720999 |
| Dated: | 2022.03.09 |
Person Responsible for Regulatory Compliance
| Name: | Mr. Mohit Kumar |
|---|---|
| Title: | Sr. Research Engineer |
| Email Id: | m.kumar@auxein.com |
| Dated: | 2022.03.09 |
Throughout the submission of 2.4 mm Radius System is covered under 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: 2.4 mm Radius System
Common or Usual Name: Plate, Fixation Bone (Primary) Screw Fixation, Bone
Classification Name:
Single/multiple component metallic bone fixation appliances and accessories (Primary) Smooth or threaded metallic bone fixation fastener
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Product Code:
HRS (Primary) HWC
Device Class: II
Review Panel: Orthopedic
Regulation Number:
21 CFR 888.3030 (Primary) 21 CFR 888.3040
Primary Product Code, Classification Name, Common Name & Regulation number Identification
| Product Code | Classification Name | Common Name | Regulation Number |
|---|---|---|---|
| HRS | Single/multiplecomponent metallicbone fixationappliances andaccessories | Plate, Fixation Bone | 21 CFR 888.3030 |
A.3) Identification of the Predicate Device:
Following are the predicate device 510(K) with which we are declaring substantial equivalence: The following is the range of variants covered with their corresponding predicate devices.
Primary Predicate:
| 510K Number | K012114 |
|---|---|
| Applicant | Synthes, USA |
| Common Name | Bone Fixation Plates |
| Device Name | 2.4mm Distal Radius System |
Reference Predicate:
| 510K Number | K040777, K091644 |
|---|---|
| Applicant | Synthes, USA |
| Common Name | Bone Fixation Plates |
| Device Name | 2.4mm Distal Radius System |
| 510K Number | K091644 |
|---|---|
| Applicant | Synthes, USA |
| Common Name | Bone Fixation Plates |
| Device Name | 2.4mm Distal Radius System |
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| 510K Number | K083694, K110125 |
|---|---|
| Applicant | Synthes, USA |
| Common Name | Bone Fixation Plate |
| Device Name | 2.4mm VA LCP System |
| 510K Number | K102694 |
|---|---|
| Applicant | Synthes, USA |
| Common Name | Bone Fixation Screws |
| Device Name | Locking Screw |
| 510K Number | K033975 |
|---|---|
| Applicant | Synthes, USA |
| Common Name | Bone Fixation Screws |
| Device Name | Locking Screw |
A.4) A description of the device that is the subject of the pre market notification submission, such as might be found in the labelling or promotional material for the device.
Device Description:
The 2.4mm Radius System consists of various types of bone plates, screws for implantation in the radius bone to treat the radius bone fracture.
2.4mm Wise-Lock "T" Distal Radius Dorsal Plate
- The shaft portion of the plate features a Combi & Capsule and the head portion features round holes. The plates are available with 3 & 4 shaft holes. This plate is available in 40.1 mm and 49.1 mm length. The plate is 2 mm thick.
- The 2.4mm Wise-Lock "T" Distal Radius Dorsal Plate are intended for fixation of complex intraextra articular fractures and osteotomies of the distal radius and other small bones.
2.4mm Wise-Lock Distal Radius Dorsal Plate, Straight:
- The shaft portion of the plate features a Combi, capsule and round holes. The plates are available with ● 5 & 6 Shaft holes. It is available in 48.7 mm & 57.7 mm length. Plate thickness is 2mm.
- The 2.4mm Wise-Lock Distal Radius Dorsal Plate, Straight are intended for fixation of complex intra-● extra articular fractures and osteotomies of the distal radius and other small bones.
2.4mm Wise-Lock "L" Distal Radius Dorsal Plate, (2 & 3 Head Holes), Left & Right:
- Plate features locking compression holes and round locking holes that accepts 2.4mm cortical and locking screws. Plate Thickness is 2 mm.
- There are 2 and 3 head holes, In 2 & 3 head holes, length of the plate varies from 40.1 mm to 49.1 mm.
- There is an oblique plate in this plate having 3 Head holes and it is available in 43.6 mm to 52.6 mm ● length.
- The 2.4mm Wise-Lock "L" Distal Radius Dorsal Plate are intended for fixation of complex intra-extra
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articular fractures and osteotomies of the distal radius and other small bones.
2.4mm Wise-Lock Distal Radius Volar Plate, Left & Right (5 Head Holes):
- The shaft portion of the plate features Combi holes and the head portion features round holes. The plates are available with 5 head holes for both the left and right side. The system consists of a variety of bone plates and fixed angle bone screws. These plates are available in 45 mm, 63 mm in length and 2mm thick.
- The 2.4 mm Wise Lock Distal Radius Volar Plate are Intended for extra-articular and intra-articular ● fractures of the proximal radius and for multi-fragmented radial neck fractures.
2.4mm Wise-Lock Distal Radius Volar Plate, Extra-articular (4 & 5 Head Holes), Left & Right:
- The shaft portion of the plate features Combi holes and the head portion features round holes. The plates are available with 4 & 5 head holes for both the left and right side. The system consists of a variety of bone plates and fixed angle bone screws.
- Plate having 4 head holes are available in 48.6 mm & 66.6 mm length and the plates having 5 Head Holes are available in 49.1 mm and 67.1 mm length.
- The 2.4mm Wise-Lock Distal Radius Volar Plate, Extra-articular implants are intended for extraarticular and intra-articular fractures of the proximal radius and for multi-fragmented radial neck fractures.
2.4mm Wise-Lock Volar Buttress Plate, left & Right (5 Head Holes):
- Volar Plates are pre contoured for anatomic fit on the volar aspect of the distal radius. Volar Plates are pre contoured for anatomic fit on the volar aspect of the distal radius. Plate available with 5 head holes & 3 shaft holes. The plates are left & right configured.
- Length of the plate is 55.6 mm.
- 2.4mm Wise- Lock Volar Buttress Plate are intended for extra-articular and intra-articular fractures of ● the proximal radius and for multi-fragmented radial neck fractures.
2.4mm Wise-Lock Volar Column Distal Radius Plate, Left & Right (8 & 9 Head Holes):
- Plate features locking compression holes and round locking holes that accepts 2.4mm cortical and ● locking screws. Plate available with 5 head holes & 3 shaft holes. The plates are left & right configured.
- 8 head holes plate are available in 49 mm, 58 mm, 67 mm length and 9 head holes plates are available in 49.6 mm, 58.6 mm & 67.6 mm length. Plate thickness is 2.20 mm.
- The 2.4mm Wise-Lock Volar Column Distal Radius Plate are intended for fixation of complex intra and extra-articular fractures of and osteotomies of the distal radius and other small bones.
2.4mm Wise-Lock Proximal Radius Plate for Radius Head Rim (5 Head Holes), Left & Right:
- Plate features locking compression holes and round locking holes that accepts 2.4mm cortical and locking screws and available with 2,3 & 4 shaft holes. The plates are left & right configured.
- This Plate is available in 36.2 mm, 46 mm and 55.58 mm length. Plate Thickness is 1.7 mm. ●
- The 2.4mm Wise-Lock Proximal Radius Plate for Radial Head Rim implants is indicated for extraarticular and intra-articular fractures of the proximal radius and for multi-fragmented radial neck fractures.
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2.4mm Wise-Lock Proximal Radius Plate for Radial Head Neck (5 Head Holes):
- . Plate features locking compression holes and round locking holes that accepts 2.4mm cortical and locking screws and available with 2, 3 & 4 shaft holes.
- This plate is available in 31.40 mm, 41.20 mm and 51.0 mm length having 1.7 mm plate thickness.
- The 2.4mm Wise-Lock Proximal Radius Plate for Radial Head Neck are intended for extra-articular and intra-articular fractures of the proximal radius and for multi-fragmented radial neck fractures.
2.4mm Wise-Lock distal radius volar plate extra-long (4 head holes):
- Volar Plates are precontoured for anatomic fit on the volar aspect of the distal radius. Plate features locking compression holes and round locking holes that accepts 2.4mm cortical and Wise-lock screws and available with 4 head holes & 8,10,12 shaft holes, Plates are left & right configured.
- Available in 99mm, 119mm, 139mm length with 2 mm plate thickness.
- The 2.4mm Wise-Lock Distal Radius Volar Plate, Extra-Long implant components are temporary implants that are intended for extra-articular and intra-articular fractures of the proximal radius and for multi-fragmented radial neck fractures.
2.4mm Variable Angle Two-Column Volar Distal Radius Plate (6 & 7 head Holes):
- The shaft portion of the plate features Combi holes and the head portion features locking star holes. The plates are available with 6 & 7 head holes and 2, 3, 4, 5 Shaft holes for both the left and right side. The system consists of a variety of bone plates and fixed angle bone screws. It is available in Titanium alloy as well as Stainless steel. Plate thickness is 2.3 mm.
- There are three types of plates i.e. Narrow head, Standard head & Wide head.
- Narrow Head:It have 6 hole head and width of 19.5 mm.
- Standard Head: It have 6 hole head and width of 22 mm.
- Wide Head: It have 7 hole head and width of 25.5 mm. ●
- . Anatomically contoured Volar Distal radius plates designed to address both simple and complex fractures, Variable Angle Holes in the head of the plate combined with Variable Angle Locking Screws offer a locked construct to support the articular surface and reduce the need for bone graft.
- 2.4mm Variable Angle Two-Column Volar Distal Radius Plate are intended for fixation of complex ● intra and extra-articular fractures and osteotomies of the distal radius and other small bones.
2.4mm Variable Angle Volar Rim Distal Radius plate (6 & 7 Head Holes):
- The shaft portion of the plate features Combi holes and the head portion features locking star holes. The plates are available with 6 & 7 head holes and 3, 4, 5, 6, 7, 8 Shaft holes for both the left and right side. The system consists of a variety of bone plates and fixed angle bone screws. It is available in Titanium alloy as well as Stainless steel.
- Plate Length is 57 mm and thickness is 2.05mm.
- 2.4mm Variable Angle Volar Rim Distal Radius plate are intended for fixation of fracture of complex intra and extra-articular fractures of the distal radius and small bones in adults, skeletally mature adolescents, and the following adolescents distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
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2.7 mm Cortical Screw, Self-Tapping, Hex Head
- This screw is available in Titanium, for use in combi holes, used to provide compression or neutral fixation, 6 mm to 30 mm lengths (2 mm increments).
2.4 mm Cortical Screw, Self-Tapping, Hex Head
- This screw is available in Titanium, used in round or Combi holes, Low-profile head in the plate holes, used to provide compression or neutral fixation, 6 mm to 30 mm lengths (2 mm increments).
2.4 mm Wise-Lock Screw, Self-Tapping, Hex Head
- This screw is available in Titanium, threaded, conical head locks securely into the threaded holes in the plate to provide angular stability, locked screws allow uni cortical screw fixation and load transfer to the near cortex, 6 mm to 30 mm lengths (2 mm increments).
2.4 mm Wise-Lock Screw, Self-tapping, Star Head
- This screw is available in Titanium and Stainless Steel, Threaded, conical head locks securely into the threaded holes in the plate to provide angular stability, Locked screws allow uni cortical screw fixation and load transfer to the near cortex, 6 mm to 30 mm lengths (2 mm increments).
2.4mm Variable Angle Screw, Self-Tapping, Star head
- This screw is available in Titanium and Stainless Steel, Rounded head locks securely into the threaded variable angle holes in the plate to provide angular stability, Gives the surgeon the ability to create a fixed-angle construct with a freedom of +/-15 degree off-axis screw angulation, 6 mm to 30 mm lengths (2 mm increments).
2.4 mm Cortical Screw, Self-Tapping, Star Head
- This screw is available in Titanium and Stainless Steel, For use in round or Combi holes, Low-profile ● head in the plate holes, Used to provide compression or neutral fixation, 6 mm to 30 mm lengths (2 mm increments).
2.7 mm Cortical Screw, Self-Tapping, Star Head
- This screw is available in Titanium and Stainless Steel, for use in Combi holes in the shaft , Used to provide compression or neutral fixation, 6 mm to 30 mm lengths (2 mm increments).
These implants are sold in both non-sterile and sterile conditions.
Note- Non sterile products have to be sterilized before use.
The system is indicated for use in adult patients only. All implants are for single use only.
A.5) A statement of the intended use of the device. Indications for Use:
2.4mm Wise-Lock Distal Radius System:
2.4mm Wise-Lock Distal Radius System are used for displaced extra-articular and intra-articular distal radius fractures and corrective osteotomies of the distal radius.
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2.4mm Wise-Lock Proximal Radius System:
2.4mm Wise-Lock Proximal Radius System are used for extra-articular and intra-articular fractures of Proximal radius and multifragmented radial neck fractures.
2.4mm Variable Angle Distal Radius System:
2.4mm Variable Angle Distal Radius System are used for displaced extra-articular and intra-articular distal radius fractures and corrective osteotomies of the distal radius.
A.6) Summary of Technological Characteristics as compared to the predicate devices: Substantial equivalence including comparison with predicate devices.
A comparison between the 2.4 mm Radius 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 | Subject Device (Auxein) | Predicate Device | Remarks |
|---|---|---|---|---|
| 1. | Product Code | HWC (Primary), HRS | HWC (Primary), HRS | Same aspredicatedevice |
| 2. | RegulationNumber | 21 CFR 888.3030(Primary), 21 CFR888.3040 | 21 CFR 888.3030 (Primary), 21CFR 888.3040 | Same aspredicatedevice |
| 3. | RegulatoryClass | Class II | Class II | Same aspredicatedevice |
| 4. | Indicationsfor use | 2.4mm Wise-Lock DistalRadius System:2.4mm Wise-Lock DistalRadius System are used fordisplaced extra-articularand intra-articular distalradius fractures andcorrective osteotomies ofthe distal radius.2.4mm Wise-LockProximal Radius System:2.4mm Wise-LockProximal Radius Systemare used for extra-articularand intra-articular fracturesof Proximal radius andmultifragmented radialneck fractures. | 2.4mm LCP Distal RadiusSystem:2.4mm LCP Distal RadiusSystem are used for displacedextra-articular and intra-articular distal radius fracturesand corrective osteotomies ofthe distal radius.2.4mm LCP Proximal RadiusSystem:2.4mm LCP Proximal RadiusSystem are used for extra-articular and intra-articularfractures of Proximal radius andmultifragmented radial neckfractures.2.4mm VA LCP Radius | Same aspredicatedevice. |
| 2.4mm Variable AngleDistal Radius System:2.4mm Variable AngleDistal Radius System areused for displaced extra-articular and intra-articulardistal radius fractures andcorrective osteotomies ofthe distal radius. | System:2.4mm VA LCP Radius Systemare used for displaced extra-articular and intra-articulardistal radius fractures andcorrective osteotomies of thedistal radius. | |||
| 2. | Material | Titanium Alloy as perASTM F136 and StainlessSteel as per ASTM F138. | Titanium Alloy as per ASTMF136 and Stainless Steel as perASTM F138. | Same aspredicatedevice. |
| 3. | MechanicalPerformanceStandards | The performance testingwas done on the subjectdevice as per the standardASTM F382 and F543. | The performance testing wasdone on the predicate device asper the standard ASTM F382and F543. | Same aspredicatedevice. |
| 4. | Sterilization | Gamma SterilizationMethod and Non-Sterileused in subject device. | Gamma Sterilization Methodand Non-Sterile was used in thepredicate devices. | Same inpredicatedevice. |
| 5. | DimensionalVerification | Same dimension as of Predicate device. | Same aspredicatedevice. | |
| 6. | Shelf-life | 5 Years | 5 Years | Same aspredicatedevice |
| 7. | SingleUse/Reuse | Single Use | Single Use | Same aspredicatedevice |
| 8. | OperatingPrinciple | The plate is fixed to thebone by application ofscrews on both sides of thefracture. | The plate is fixed to the boneby application of screws onboth sides of the fracture. | Same aspredicatedevice |
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B.1) Discussion on the non-clinical testing performed
Following are the applicable product standards considered for non-clinical standards:
- Material Standards.
- Biocompatibility Standards
- Performance Standards.
- · Sterilization, shelf-life and packaging for sterile product.
- Bacterial Endotoxin
Non-Clinical Test Summary:
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Bench tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with the following standards:
Material Standards:
The material standards are the essential part to be complied with first, as it is the basis of manufacturing metallic surgical implants.
We have complied with the following material standards:
- ASTM F136/ISO 5832-3: Standard specification for wrought Titanium-6 Vanadium ● ELI (Extra low interstitial) Alloy for surgical implant applications.
- ASTM F899-12: Standard Specification for Wrought Stainless Steels for surgical instruments. ●
- ASTM F138/ISO 5832-1: Standard Specification for Wrought-18 Chromium-14 Nickel-2.5 . Molybdenum Stainless Steel Bar and Wire for Surgical Implants.
Note: We have used Grade 304 of Stainless steel (SS 304) Material for instruments as per ASTM F899-12b, Stainless Steel (Grade 316L) as per ISO 5832-3/ASTM F138 for Stainless Steel Implants and Titanium Alloy (Ti-6Al-4V) Grade 5 as per ISO 5832-1/ASTM F136 for Titanium Implants.
We have verified the purchased material and are in compliance to these standards and copies of the relevant test results are attached in Vol_005_Appendix D Implant Material Report and Vol_006_ Appendix E ASTM F899 Report of the technical dossier.
Summary of Biocompatibility
The Raw materials have been evaluated for biocompatibility according to ISO 10993-3.
Conclusion of Non-Clinical Testing
- · ASTM F382, Standard Specification and Test Method for Metallic Bone Plates.
- · ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws.
The following tests were performed with the predicate and subject device:
Plate
- 4-Point Static Test: Conforms
- · 4-Point Fatigue Test: Conforms
Screw
- Driving Torque Test: Conforms
- Torsion Test: Conforms
- Axial Pull-out Test: Conforms
The conclusion of this non-clinical indicates that the 2.4mm Radius System is equivalent to the predicate devices.
Sterilization, shelf-life and packaging for sterile product
- · ISO 11137-1:2006, sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
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- ISO 11137-2:2012, Sterilization of health care products Radiation Part 2: Establishing the . sterilization dose.
- ISO 11137-3:2017, Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control.
- ISO 17665-1:2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
- ISO/TS 17665-2:2009, Sterilization of health care products Moist heat Part 2: Guidance on ● the application of ISO 17665-1.
- ISO/TS 17665-3:2013(en), Sterilization of health care products -- Moist heat -- Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization.
- ISO 11140-1:2014, Sterilization of health care products — Chemical indicators — Part 1: General requirements.
- ISO 11737-1:2018 Sterilization of medical devices - Microbiological methods- Part 1: Estimation of population of microorganisms on products.
- . ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods- Part 2: Tests of sterility performed in the validation of a sterilization process.
- ISO 11607-1:2006/AMD1:2014 Packaging for terminally sterilized medical devices - part 1: requirements for materials, sterile barrier systems and packaging system.
- ISO 11607-2:2006/AMD1:2014 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
- . ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
- ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
Bacterial Endotoxin
- USP <85> Bacterial Endotoxin Test. ●
- USP <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests. .
Conclusion:
There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, and operational principles as internal fixation components. From the data available we can justify that the Auxein's 2.4mm Radius System is as safe, and as effective and performs the same indications for use as that of already marketed predicate devices identified in A.3. of 510(k) summary.
§ 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.