(340 days)
Not Found
No
The 510(k) summary describes a mechanical implant system for fracture fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as "intended for femoral fracture fixation and promoting femoral fracture healing," which directly aligns with the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The device is a system of nails, screws, and instruments intended for femoral fracture fixation and healing, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the system consists of physical implants (nails, spiral blades, locking screws, end caps) and related instruments, all made of metallic materials. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "femoral fracture fixation and promoting femoral fracture healing." This is a surgical procedure performed directly on the patient's body to treat a physical condition.
- Device Description: The device consists of "nails, spiral blades, locking screws, end caps and related instrument." These are implants and surgical tools used in a surgical setting.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The Double Medical Femoral Nail System is a surgical implant/device used for orthopedic procedures, not an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
Double Medical Femoral Nail System is intended for femoral fracture fixation and promoting femoral fracture healing.
Indications for use of the Proximal Femoral Nail, Anti-rotation, short; and Anatomical Proximal Femoral Nail (APFN ), short (Length 170 mm - 240 mm) include:
- Pertrochanteric fractures (31-A1 and 31-A2);
- Intertrochanteric fractures (31-A3);
- High subtrochanteric fractures (32-A1).
Indications for use of the Proximal Femoral Nail. Anti-rotation. long (Length 300 mm - 420 mm), Anatomical Proximal Femoral Nail (APFN ), long (Length 300 mm - 480 mm) include:
- Low and extended subtrochanteric fractures;
- Ipsilateral trochanteric fractures;
- Combination fractures (in the proximal femur);
- Pathological fractures.
Indications for use of the Universal Femoral Nail, Cannulated (UFN I) include:
- Femoral shaft fractures.
Indications for use of the Universal Femeral Nail II, Cannulated (UFN II) include:
- Standard Locking UFN II: femoral shaft fractures;
- Reconstruction Locking UFN II : femoral shaft combined with femoral neck fractures.
Product codes
HSB, HWC
Device Description
Double Medical Femoral Nail System consists of a series of nails, spiral blades, locking screws, end caps and related instrument. The implants are provided in a variety of lengths and anatomical designs to accommodate the medullary canal of femur. All of the implants in the Double Medical Femoral Nail System are made of made of Ti-6AI-4V following ISO 5832-3 or Ti-6Al-4V ELI following ASTM F 136, which are widely used for surgical implants with well-known biocompatibility. Double Medical Femoral Nail System is provided as non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, femur
Indicated Patient Age Range
Not Found
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 tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
The test results demonstrated that the proposed device conforms to ASTM F1264-16e1 Standard Specification and Test Methods for Intramedullary Fixation Devices, ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws, ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices, including:
- Static Four-point Bending Test of Nail
- Dynamic Four-point Bending Test of Nail
- Static Torsion Test of Nail
- Static Three-point Bending Test of Locking Screw
- Dynamic Three-point Bending Test of Locking Screw
- Insertion/removal Test of Locking Screw
- Pullout Test of Locking Screw
- Torsion Test of Locking Screw.
- Cantilever Bending Test
- Insertion/removal test, static torsion and axial pullout test of Lag Screw
- Cut-out Test
No clinical performance data is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
August 24, 2018
Double Medical Technology Inc. Yan Zuo Regulatory Specialist No. 18. Shanbianhong East Road. Haicang District Xiamen, Fujian 361026 People's Republic of China
Re: K172830
Trade/Device Name: Double Medical Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, HWC Dated: June 28, 2018 Received: June 28, 2018
Dear Yan Zuo:
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
1
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Peter G. Allen -S 2018.08.24 14:52:30 -04'00'
- FOR: Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K172830
Device Name Double Medical Femoral Nail System
Indications for Use (Describe)
Double Medical Femoral Nail System is intended for femoral fracture fixation and promoting femoral fracture healing.
Indications for use of the Proximal Femoral Nail, Anti-rotation, short; and Anatomical Proximal Femoral Nail (APFN ), short (Length 170 mm - 240 mm) include:
-
Pertrochanteric fractures (31-A1 and 31-A2);
-
Intertrochanteric fractures (31-A3);
-
High subtrochanteric fractures (32-A1).
Indications for use of the Proximal Femoral Nail. Anti-rotation. long (Length 300 mm - 420 mm), Anatomical Proximal Femoral Nail (APFN ), long (Length 300 mm - 480 mm) include:
-
Low and extended subtrochanteric fractures;
-
Ipsilateral trochanteric fractures;
-
Combination fractures (in the proximal femur);
-
Pathological fractures.
Indications for use of the Universal Femoral Nail, Cannulated (UFN I) include:
- Femoral shaft fractures.
Indications for use of the Universal Femoral Nail II, Cannulated (UFN II) include:
-
Standard Locking UFN II: femoral shaft fractures;
-
Reconstruction Locking UFN II : femoral shaft combined with femoral neck fractures.
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."
3
Section 3 510(k) Summary
3.1 Submitter
Double Medical Technology Inc. No. 18, Shanbianhong East Road, Haicang District, Xiamen, 361026, P. R. China
Tel: 86-592-6587078 Fax: 86-592-6087671 Email: intl ra@double-medical.com; zuoyan@double-medical.com
Contact Person: Yan Zuo Date Prepared: Jun. 26th, 2018
3.2 Proposed Device
Trade /Proprietary Name: Double Medical Femoral Nail System Common or Usual Name: Double Medical Femoral Nail System Classification Name: Intramedullary fixation rod Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3020, 888.3040 Regulatory Classification: Class II Product Code: HSB, HWC
3.3 Predicate Device
| K070761 | Sanatmetal Intramedullary Nails and Pins |
|---|---|
| K043431 | Stryker Gamma3® Nail System |
| K040336 | Synthes (USA) Lateral Entry Femoral Nail System |
3.4 Device Description
Double Medical Femoral Nail System consists of a series of nails, spiral blades, locking screws, end caps and related instrument. The implants are provided in a variety of lengths and anatomical designs to accommodate the medullary canal of femur. All of the implants in the Double Medical Femoral Nail System are made of made of Ti-6AI-4V
4
following ISO 5832-3 or Ti-6Al-4V ELI following ASTM F 136, which are widely used for surgical implants with well-known biocompatibility. Double Medical Femoral Nail System is provided as non-sterile.
3.5 Indication for Use
Double Medical Femoral Nail System is intended for femoral fracture fixation and promoting femoral fracture healing.
- A Indications for use of the Proximal Femoral Nail, Anti-rotation, short; and Anatomical Proximal Femoral Nail (APFN ), short (Length 170 mm - 240 mm) include:
- । Pertrochanteric fractures (31-A1 and 31-A2);
- । Intertrochanteric fractures (31-A3);
- High subtrochanteric fractures (32-A1).
- Indications for use of the Proximal Femoral Nail, Anti-rotation, long (Length 300 mm -A 420 mm). Anatomical Proximal Femoral Nail (APFN ). long (Length 300 mm - 480 mm) include:
- Low and extended subtrochanteric fractures:
- Ipsilateral trochanteric fractures: ।
- । Combination fractures (in the proximal femur);
- Pathological fractures.
- Indications for use of the Universal Femoral Nail, Cannulated (UFN I) include: A
- Femoral shaft fractures.
- A Indications for use of the Universal Femoral Nail II, Cannulated (UFN II) include:
- | Standard Locking UFN II: femoral shaft fractures;
। Reconstruction Locking UFN II : femoral shaft combined with femoral neck fractures, subtrochanteric fractures.
3.6 Comparison with the Predicate Device
The rationale for substantial equivalence is based on consideration of the following characteristics:
Regulatory Classification: Same as the predicate devices
Indications for Use: Substantially equivalent (SE) to the predicate devices
Materials: Substantially equivalent (SE) to the predicate devices
Design Features: Substantially equivalent (SE) to the predicate devices
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3.7 Non-Clinical Performance Data
Non-Clinical tests were conducted to verify that the proposed device met all design
specifications as was Substantially Equivalent (SE) to the predicate device.
The test results demonstrated that the proposed device conforms to ASTM F1264-16e1 Standard Specification and Test Methods for Intramedullary Fixation Devices, ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws, ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices, including:
- Static Four-point Bending Test of Nail
- Dynamic Four-point Bending Test of Nail
- Static Torsion Test of Nail
- Static Three-point Bending Test of Locking Screw
- Dynamic Three-point Bending Test of Locking Screw
- Insertion/removal Test of Locking Screw
- Pullout Test of Locking Screw
- Torsion Test of Locking Screw.
- Cantilever Bending Test
- Insertion/removal test, static torsion and axial pullout test of Lag Screw
- Cut-out Test
3.8 Clinical Performance Data
No clinical performance data is included in this submission.
3.9 Substantially Equivalent
The proposed device is compared to the predicate devices in respect of safety and effectiveness. The information provided within this premarket notification demonstrates that proposed device is determined to be Substantially Equivalent (SE) to the predicate device.