(527 days)
No
The summary describes a mechanical orthopedic implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended for use in treating fractures of the femoral head and condylar part of the femur, which directly addresses a medical condition.
No
Explanation: The device description states its purpose is "treating fractures," and the system is composed of "plates, compression screw and bone screws," which are types of implants used for orthopedic fixation rather than diagnosis.
No
The device description explicitly states it is composed of plates, compression screws, and bone screws made from Stainless Steel or Titanium alloy, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for treating fractures of the femoral head and condylar part of the femur. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a system of plates, compression screws, and bone screws made of metal. These are implants used to fix bones, not reagents or instruments for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for fracture fixation.
N/A
Intended Use / Indications for Use
The DHS/DCS Plate System is intreating fractures of femoral head (Dynamic Hip Plates) and condylar part of the femur (Dynamic Condylar Plates).
Specific indications, which are dependent on the angle of the plate, include:
130°-135°: fractures of the trochanter region, simple and multifragmentary pertrochanteric, intertrochanteric.
95°: distal and intercondylar fractures of the femur.
Product codes (comma separated list FDA assigned to the subject device)
KTT, KTW, HRS, HWC
Device Description
The Auxein's DHS/DCS Plate System offers a variety of treatment options depending on the fracture site and the patient. The DHS/DCS Plate System is composed of plates, compression screw and bone screws. The devices are made from either Stainless Steel as per ASTM F138-19 or Titanium alloy as per ASTM F136-13(2021)e1.
These implants will be available either in sterile or non-sterile state.
Note- Non sterile products have to be sterilized before use.
The system is indicated for use in skeletally mature patients only. All implants are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head, condylar part of the femur, trochanter region
Indicated Patient Age Range
skeletally mature 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)
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:
Biocompatibility: evaluated according to ISO 10993.
Bone Plates: ASTM F384-17 (Static four point bend test, Fatigue four point bend test).
The Auxein's DHS/DCS Plate System was mechanically tested for static and fatigue four point bend, with test results similar to those of predicates. The performance of the subject device was assessed through tests. According to the results, the Auxein's DHS/DCS Plate System is considered substantially equivalent to the predicate device.
Sterilization, shelf-life and packaging for sterile product: ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 17665-1, ISO/TS 17665-2:2009, ISO/TS 17665-3, ISO 11140-1, ISO 11737-1, ISO 11737-2, ISO 11607-1, ISO 11607-2, ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-15.
Bacterial Endotoxin: USP Bacterial Endotoxin Test, USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests.
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.
K071852, K052677, K840954, K914546, K791619
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.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 30, 2023
Auxein Medical Private Limited Rahul Luthra Director Plot No. 168-169-170, Phase-4, Kundli Industrial Area, HSIIDC, Sector-57 Sonipat-131028. Haryana India
Re: K221787
Trade/Device Name: Auxein's Patient Specific Implant Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, KTW, HRS, HWC Dated: March 20, 2023 Received: March 22, 2023
Dear 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. 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-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,
Limin Sun -
Limin Sun, Ph.D., Assistant 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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
510(k) Number (if known) K221787
Device Name Auxein's DHS/DCS Plate System
Indications for Use (Describe)
Indications for Use (Describe)
The DHS/DCS Plate System is intreating fractures of femoral head (Dynamic Hip Plates) and condylar part of the femur (Dynamic Condylar Plates).
Specific indications, which are dependent on the angle of the plate, include:
130°-135°: fractures of the trochanter region, simple and multifragmentary pertrochanteric, intertrochanteric.
95°: distal and intercondylar fractures of the femur.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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and review the collection of information. Send comments regardin and review the collection of information for reducing this burden, to:
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FORM FDA 3881 (8/23)
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Image /page/3/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it. To the right of the circle is the word "Auxein" in blue, with a registered trademark symbol next to it.
510(k) 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 Limited |
| Plot 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 |
| Email Id: | rahul@auxein.com |
| Dated: | 2023.11.30 |
| Secondary Contact |
| Name: | Mr. Mohit Kumar |
|---|---|
| Title: | Manager-Regulatory Affairs |
| Email Id: | m.kumar@auxein.com |
| Dated: | 2023.11.30 |
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's DHS/DCS Plate System
Common or Usual Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Classification Name:
Single/multiple component metallic bone fixation appliances and accessories
Primary Product Code:
KTT
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Image /page/4/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, with a trademark symbol next to it. The logo is simple and modern, and the blue color gives it a sense of trust and reliability.
Additional Product Code:
HRS, KTW, HWC
Device Class: II
Review Panel: Orthopedic
Regulation Number:
21 CFR 888.3030 (Primary) 21 CFR 888.3040
Variants/Types:
Auxein's DHS/DCS Plate System consists of the following Components:
| S.No. | Product Description |
|---|---|
| DHS/DCS Plates | |
| 1. | Wise-Lock Dynamic Hip System (DHS) Plate |
| 2. | 4.5/5.0mm Wise-Lock Trochanter Stabilizing Plate for DHS-Adjustable |
| 3. | 135° Wise-Lock DHS Plate, Short Barrel |
| 4. | 95° Wise-Lock DCS Plate |
| 5. | 95° Condylar Blade Plate |
| 6. | 130°Angled Blade Plate |
| 7. | 135° Dynamic Hip Compression Plate, Short Barrel |
| 8. | Dynamic Hip Compression Plate |
| 9. | 95° DCS Plate |
| Screws | |
| 1. | DHS/DCS Screw |
| 2. | DHS/DCS Compression Screw |
| 3. | 4.5mm Cortical Screw, Self-Tapping, (Hex Head) |
| 4. | 5.0mm Wise-Lock Screw, Self-Tapping, (Hex Head) |
| 5. | 6.5mm Cancellous Screw, 16mm Thread |
| 6. | 6.5mm Cancellous Screw, 32mm Thread |
| 7. | 6.5mm Cancellous Screw, Full Thread |
A.3) Identification of the Predicate Device:
Following are the predicate device 510(k)s which we are declaring substantial equivalence:
Primary Predicate Device
| 510k Number | K071852 |
|---|---|
| ------------- | --------- |
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K221787 Page 3/6
Image /page/5/Picture/1 description: The image features the logo for "Auxein". The logo consists of a stylized letter "A" enclosed in a circle, followed by the word "Auxein" in a sans-serif font. The entire logo is rendered in a light blue color. There is a registered trademark symbol next to the word "Auxein".
| Applicant | aap Implantate AG (Germany) |
|---|---|
| Common Name | Appliance, fixation, nail/blade/plate combination, single component |
| Device Name | Dynamic Hip Screw |
Additional Predicate Devices
| 510k Number | K052677 |
|---|---|
| Applicant | Synthes (USA) |
| Device Name | Synthes Universal Locking Trochanter Stabilization Plate (ULTSP) |
| 510k Number | K840954 |
|---|---|
| Applicant | Synthes (USA) |
| Device Name | Dynamic Condylar Screw Or D.C.S. |
| 510k Number | K914546 |
|---|---|
| Applicant | Synthes (USA) |
| Device Name | Angled Blade Plate |
| 510k Number | K791619 |
|---|---|
| Applicant | Synthes (USA) |
| Device Name | Dynamic Hip Screw (DHS)/DCS Compression Screw |
Reference Device
| 510k Number | K213059 |
|---|---|
| Applicant | Auxein Medical Private Limited, India |
| Common Name | Orthopaedic bone plates, Orthopaedic bone screws |
| Device Name | Tibia and Fibula system |
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 Auxein's DHS/DCS Plate System offers a variety of treatment options depending on the fracture site and the patient. The DHS/DCS Plate System is composed of plates, compression screw and bone screws. The devices are made from either Stainless Steel as per ASTM F138-19 or Titanium alloy as per ASTM F136-13(2021)e1.
These implants will be available either in sterile or non-sterile state.
Note- Non sterile products have to be sterilized before use.
The system is indicated for use in skeletally mature patients only. All implants are for single use only.
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Image /page/6/Picture/1 description: The image features the logo for "Auxein". The logo consists of a stylized letter "A" enclosed in a circle, followed by the word "Auxein" in a sans-serif font. A registered trademark symbol is located to the right of the word "Auxein". The logo is presented in a blue color.
A.5) Indications for Use:
The DHS/DCS Plate System is intended for use in treating fractures of femoral head (Dynamic Hip Plates) and condylar part of the femur (Dynamic Condylar Plates).
Specific indications, which are dependent on the angle of the plate, include:
- 130°-135°: fractures of the trochanter region, simple and multifragmentary pertrochanteric, intertrochanteric.
- 95°: distal and intercondylar fractures of the femur.
A.6) Summary of Technological Characteristics as compared to the predicate devices: Substantial equivalence including comparison with predicate devices.
A comparison between the Auxein's DHS/DCS Plate System and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.
The subject implants are similar to the predicates because they are made from the same materials. The subject plates have similar plate lengths, thickness, and widths. The subject plates are also compatible with the same types of screws and same sized screws as the predicates. The subject and predicates differ in their specific geometries (e.g., tolerances, locking thread profile, screw hole sizes and patterns on the plate).
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:
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:
Summary of Biocompatibility
The device has been evaluated for biocompatibility according to ISO 10993.
Conclusion of Non-Clinical Testing
The device's performance of has been demonstrated against the following standards:
Bone Plates
ASTM F384-17: Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices.
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Image /page/7/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it. To the right of the circle is the word "Auxein" in blue, with a registered trademark symbol next to it.
- Static four point bend test
- . Fatigue four point bend test
The Auxein's DHS/DCS Plate System was mechanically tested for static and fatigue four point bend, with test results similar to those of predicates. The performance of the subject device was assessed through tests. According to the results, the Auxein's DHS/DCS Plate System is considered substantially equivalent to the predicate device.
Sterilization, shelf-life and packaging for sterile product
- ISO 11137-1:2006/Amd 2:2018, sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
- ISO 11137-2:2013/Amd 1:2022, 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, 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/Amd 1:2021, Sterilization of medical devices - Microbiological methods- Part 1: Estimation of population of microorganisms on products.
- ISO 11737-2:2019, Sterilization of medical devices - Microbiological methods- Part 2: Tests of sterility performed in the validation of a sterilization process.
- ISO 11607-1:2019, Packaging for terminally sterilized medical devices - part 1:requirements for materials, sterile barrier systems and packaging system.
- ISO 11607-2:2019, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
- ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- ASTM F88/F88M-21, Standard test method for seal strength of flexible barrier materials.
- ASTM F1929-15, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
Bacterial Endotoxin
- USP Bacterial Endotoxin Test. .
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Image /page/8/Picture/1 description: The image shows the logo for Auxein. The logo consists of a stylized letter "A" inside of a circle, followed by the word "Auxein" in a sans-serif font. A registered trademark symbol is located to the right of the word "Auxein".
- · USP 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 DHS/DCS Plate 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.